Preterm InfantsNCT04932044
Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
A study testing Early Sleep Facilitation Program and Routine care in people with Preterm Infants and Sleep, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research. Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants, Sleep, Quality of Life
- What is being tested?
- Early Sleep Facilitation Program and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2020to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants gestational age (GA) > 28 weeks and < 37 weeks, and birth weight less than 2200 grams;
- The main caregiver of the preterm infants can communicate in Mandarin and Taiwanese;
- The parents of the preterm infants and their main caregivers agrees to participate in this research and signs the research consent form
Who cannot join
- Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia;
- Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy;
- Those who need to take muscle relaxants, sedatives or bronchodilators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction and Longitudinal Following Up the Effects of Early Sleep Facilitation Program on Preterm Infants' Sleep, Health After Discharge, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.
The proposed study has six specific aims:
- Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
- Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.
Read the detailed description
Background and purpose:
Preterm infants need to receive intensive care in a neonatal intensive care unit (NICU) to survive, but the sleep of preterm infants is disturbed by the environment of the intensive care unit, invasive treatment and care activities. When a preterm infant's sleep is interrupted, it not only affects his physical growth, behavior and emotional development, but also affects his recovery from illness and the length of hospital stay, and even affects his sleep quality and development after returning home. However, medical personnel are busy with clinical practice, seldom pay attention to the sleep development of preterm infants. In the past, few studies paid attention to the factors that affect the sleep of preterm infants after returning home, and few studies also explored the sleep and physical and mental health of preterm infants and their main caregivers after returning home. Sleep intervention in preterm infants was mostly a single outcome indicator; besides, past studies lacked objective sleep instruments and long-term follow-up studies.
Based on the above research gaps, this research plan to construct an "early sleep Facilitation program" and to explore the effects of the "Early Sleep Facilitation Program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.
The proposed study has six specific aims:
- Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
- Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.
Methods:
This randomized controlled trial will adopt a longitudinal repeated measures design to examine the " Early Sleep Facilitation Program " on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver. Preterm infants and the caregiver were recruited by convenience sampling in Neonatal Intensive Care Unit and Infant Intermediate Care Unit of a medical center in northern Taiwan from July in 2020 to December in 2022. There are two different intervention modes (intervention group and control group), the intervention group receives " Early Sleep Facilitation Program " and the control group receives routine care. The program is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status after the first month and the second month after discharge. The control group receives routine care and provide general discharge care and nursing guidance. The questionnaires and physiological measurements will be used to collect the data. The two groups will collect data during hospitalization, one week before discharge, and the first month and the second month after discharge. We will use generalized estimation equations method to analyze research data.
- Conditions
- Preterm Infants, Sleep, Quality of Life
- Being tested
- Early Sleep Facilitation Program, Routine care
- Keywords
- Preterm Infants, Sleep, Quality of Life, Attachment, Actigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Sleep Facilitation ProgramBehavioural
It is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status within two months after discharge.
Routine careOther
Receives routine care and provide general discharge care and nursing guidance.
| Study group | Role | What they receive |
|---|---|---|
| Early Sleep Facilitation Program | Experimental | Perform sleep circadian rhythm training during hospitalization, and provide caregivers with nursing guidance to promote sleep of premature infants before discharge Receives: Behavioral: Early Sleep Facilitation Program; Other: Routine care |
| routine care and provide general discharge care and nursing guidance | Active comparator | Routine care and provide general discharge care and nursing guidance. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Infants' Sleep- Actigraphy -T1
Accessed by Actigraphy
Measured: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Sleep- Actigraphy -T2
Accessed by Actigraphy
Measured: T2- preterm infants one week before discharge
Preterm Infants' Sleep- Actigraphy -T3
Accessed by Actigraphy
Measured: T3- preterm infants the first month after discharge
Preterm Infants' Sleep- Actigraphy -T4
Accessed by Actigraphy
Measured: T4- preterm infants second month after discharge
Preterm Infants' Sleep- sleep log -T1
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Measured: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Sleep- sleep log -T2
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Measured: T2- preterm infants one week before discharge
Preterm Infants' Sleep- sleep log -T3
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Measured: T3- preterm infants the first month after discharge
Preterm Infants' Sleep- sleep log -T4
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Measured: T4- preterm infants second month after discharge
Preterm Infants' Health- Health Assessment Form-weight-T1
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Measured: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Health- Health Assessment Form-weight-T2
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Measured: T2- preterm infants one week before discharge
Preterm Infants' Health- Health Assessment Form-weight-T3
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Measured: T3- preterm infants the first month after discharge
Preterm Infants' Health- Health Assessment Form-weight-T4
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Measured: T4- preterm infants second month after discharge
Preterm Infants' Health- Health Assessment Form- head circumference-T1
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Measured: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Health- Health Assessment Form- head circumference-T2
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Measured: T2- preterm infants one week before discharge
Preterm Infants' Health- Health Assessment Form- head circumference-T3
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Measured: T3- preterm infants the first month after discharge
Preterm Infants' Health- Health Assessment Form- head circumference-T4
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).
Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Measured: T4- preterm infants second month after discharge
Preterm Infants' Health- Nutrition data-T1
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Measured: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Health- Nutrition data-T2
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Measured: T2- preterm infants one week before discharge
Preterm Infants' Health- Nutrition data-T3
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Measured: T3- preterm infants the first month after discharge
Preterm Infants' Health- Nutrition data-T4
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Measured: T4- preterm infants second month after discharge
Caregivers' Sleep- Actigraphy-T1
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Measured: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' Sleep- Actigraphy-T2
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Measured: T2- preterm infants one week before discharge
Caregivers' Sleep- Actigraphy-T3
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Measured: T3- preterm infants the first month after discharge
Caregivers' Sleep- Actigraphy-T4
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Measured: T4- preterm infants second month after discharge
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T1
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T2
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: T2- preterm infants one week before discharge
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T3
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: T3- preterm infants the first month after discharge
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T4
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: T4- preterm infants second month after discharge
Caregivers' Sleep- Sleep log-T1
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Measured: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' Sleep- Sleep log-T2
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Measured: T2- preterm infants one week before discharge
Caregivers' Sleep- Sleep log-T3
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Measured: T3- preterm infants the first month after discharge
Caregivers' Sleep- Sleep log-T4
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Measured: T4- preterm infants second month after discharge
Caregivers' Stress- T1
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Measured: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' Stress- T2
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Measured: T2- preterm infants one week before discharge
Caregivers' Stress- T3
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Measured: T3- preterm infants the first month after discharge
Caregivers' Stress- T4
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Measured: T4- preterm infants second month after discharge
Caregivers' quality of life-T1
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Measured: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' quality of life-T2
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Measured: T2- preterm infants one week before discharge
Caregivers' quality of life-T3
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Measured: T3- preterm infants the first month after discharge
Caregivers' quality of life-T4
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Measured: T4- preterm infants second month after discharge
Caregivers' attachment-T1
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Measured: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' attachment-T2
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Measured: T2- preterm infants one week before discharge
Caregivers' attachment-T3
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Measured: T3- preterm infants the first month after discharge
Caregivers' attachment-T4
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.
The higher the total score, the closer the maternal-infant attachment.
Measured: T4- preterm infants second month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiang-Yun Lan, National Defense Medical Center, Taiwan
- Investigators
- Hsiang-Yun Lan, Asst. Prof., Principal investigator, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932044
- Sponsor's protocol ID
- C202005014
- Status last verified
- May 2026
- First submitted
- 28 May 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Longitudinal Following Up the Effects of Early Sleep Facilitation Program on Preterm Infants' Sleep, Health After Discharge, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
- ClinicalTrials.gov ID
- NCT04932044
- Acronym / sponsor ID
- C202005014
- Conditions
- Preterm Infants, Sleep, Quality of Life
- Keywords
- Preterm Infants, Sleep, Quality of Life, Attachment, Actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.
The proposed study has six specific aims:
- Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
- Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.
Detailed description
Background and purpose:
Preterm infants need to receive intensive care in a neonatal intensive care unit (NICU) to survive, but the sleep of preterm infants is disturbed by the environment of the intensive care unit, invasive treatment and care activities. When a preterm infant's sleep is interrupted, it not only affects his physical growth, behavior and emotional development, but also affects his recovery from illness and the length of hospital stay, and even affects his sleep quality and development after returning home. However, medical personnel are busy with clinical practice, seldom pay attention to the sleep development of preterm infants. In the past, few studies paid attention to the factors that affect the sleep of preterm infants after returning home, and few studies also explored the sleep and physical and mental health of preterm infants and their main caregivers after returning home. Sleep intervention in preterm infants was mostly a single outcome indicator; besides, past studies lacked objective sleep instruments and long-term follow-up studies.
Based on the above research gaps, this research plan to construct an "early sleep Facilitation program" and to explore the effects of the "Early Sleep Facilitation Program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.
The proposed study has six specific aims:
- Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
- Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
- Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.
Methods:
This randomized controlled trial will adopt a longitudinal repeated measures design to examine the " Early Sleep Facilitation Program " on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver. Preterm infants and the caregiver were recruited by convenience sampling in Neonatal Intensive Care Unit and Infant Intermediate Care Unit of a medical center in northern Taiwan from July in 2020 to December in 2022. There are two different intervention modes (intervention group and control group), the intervention group receives " Early Sleep Facilitation Program " and the control group receives routine care. The program is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status after the first month and the second month after discharge. The control group receives routine care and provide general discharge care and nursing guidance. The questionnaires and physiological measurements will be used to collect the data. The two groups will collect data during hospitalization, one week before discharge, and the first month and the second month after discharge. We will use generalized estimation equations method to analyze research data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Sleep Facilitation Program | Experimental | Behavioral: Early Sleep Facilitation Program, Other: Routine carePerform sleep circadian rhythm training during hospitalization, and provide caregivers with nursing guidance to promote sleep of premature infants before discharge |
| routine care and provide general discharge care and nursing guidance | Active comparator | Other: Routine careRoutine care and provide general discharge care and nursing guidance. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants gestational age (GA) > 28 weeks and < 37 weeks, and birth weight less than 2200 grams;
- The main caregiver of the preterm infants can communicate in Mandarin and Taiwanese;
- The parents of the preterm infants and their main caregivers agrees to participate in this research and signs the research consent form
Key exclusion criteria (3 listed)
- Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia;
- Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy;
- Those who need to take muscle relaxants, sedatives or bronchodilators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Sleep Facilitation ProgramIt is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status within two months after discharge. | Behavioural | Early Sleep Facilitation Program |
| Routine careReceives routine care and provide general discharge care and nursing guidance. | Other | Early Sleep Facilitation Program, routine care and provide general discharge care and nursing guidance |
Primary outcome
Preterm Infants' Sleep- Actigraphy -T1
Time frame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Accessed by Actigraphy
Preterm Infants' Sleep- Actigraphy -T2
Time frame: T2- preterm infants one week before discharge
Accessed by Actigraphy
Preterm Infants' Sleep- Actigraphy -T3
Time frame: T3- preterm infants the first month after discharge
Accessed by Actigraphy
Preterm Infants' Sleep- Actigraphy -T4
Time frame: T4- preterm infants second month after discharge
Accessed by Actigraphy
Preterm Infants' Sleep- sleep log -T1
Time frame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Preterm Infants' Sleep- sleep log -T2
Time frame: T2- preterm infants one week before discharge
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Preterm Infants' Sleep- sleep log -T3
Time frame: T3- preterm infants the first month after discharge
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Preterm Infants' Sleep- sleep log -T4
Time frame: T4- preterm infants second month after discharge
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
Preterm Infants' Health- Health Assessment Form-weight-T1
Time frame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form-weight-T2
Time frame: T2- preterm infants one week before discharge
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form-weight-T3
Time frame: T3- preterm infants the first month after discharge
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form-weight-T4
Time frame: T4- preterm infants second month after discharge
The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form- head circumference-T1
Time frame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form- head circumference-T2
Time frame: T2- preterm infants one week before discharge
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form- head circumference-T3
Time frame: T3- preterm infants the first month after discharge
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Health Assessment Form- head circumference-T4
Time frame: T4- preterm infants second month after discharge
The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm). Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
Preterm Infants' Health- Nutrition data-T1
Time frame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Preterm Infants' Health- Nutrition data-T2
Time frame: T2- preterm infants one week before discharge
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Preterm Infants' Health- Nutrition data-T3
Time frame: T3- preterm infants the first month after discharge
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Preterm Infants' Health- Nutrition data-T4
Time frame: T4- preterm infants second month after discharge
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
Caregivers' Sleep- Actigraphy-T1
Time frame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Caregivers' Sleep- Actigraphy-T2
Time frame: T2- preterm infants one week before discharge
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Caregivers' Sleep- Actigraphy-T3
Time frame: T3- preterm infants the first month after discharge
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Caregivers' Sleep- Actigraphy-T4
Time frame: T4- preterm infants second month after discharge
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T1
Time frame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T2
Time frame: T2- preterm infants one week before discharge
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T3
Time frame: T3- preterm infants the first month after discharge
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T4
Time frame: T4- preterm infants second month after discharge
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Caregivers' Sleep- Sleep log-T1
Time frame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Caregivers' Sleep- Sleep log-T2
Time frame: T2- preterm infants one week before discharge
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Caregivers' Sleep- Sleep log-T3
Time frame: T3- preterm infants the first month after discharge
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Caregivers' Sleep- Sleep log-T4
Time frame: T4- preterm infants second month after discharge
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
Caregivers' Stress- T1
Time frame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Caregivers' Stress- T2
Time frame: T2- preterm infants one week before discharge
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Caregivers' Stress- T3
Time frame: T3- preterm infants the first month after discharge
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Caregivers' Stress- T4
Time frame: T4- preterm infants second month after discharge
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
Caregivers' quality of life-T1
Time frame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Caregivers' quality of life-T2
Time frame: T2- preterm infants one week before discharge
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Caregivers' quality of life-T3
Time frame: T3- preterm infants the first month after discharge
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Caregivers' quality of life-T4
Time frame: T4- preterm infants second month after discharge
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
Caregivers' attachment-T1
Time frame: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
Caregivers' attachment-T2
Time frame: T2- preterm infants one week before discharge
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
Caregivers' attachment-T3
Time frame: T3- preterm infants the first month after discharge
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
Caregivers' attachment-T4
Time frame: T4- preterm infants second month after discharge
Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiang-Yun Lan, Asst. Prof. principal investigator
National Defense Medical Center, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Sleep Facilitation Program and Routine care in people with Preterm Infants and Sleep, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm Infants' Sleep- Actigraphy -T1 (time frame: T1-baseline collect preterm infants after 32 weeks of gestation before intervention). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.