SleepNCT06664749
Sleep-wakefulness Status in Preterm Infants
A study testing Three stair position pillow group and Positioning material group in people with Sleep, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants. Read more about this study
- Who is it for?
- Ages 30 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Three stair position pillow group and Positioning material group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2023to 20 Dec 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 30 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants who were postmenstrual age ≥30 and ≤34,
- had an appropriate weight for gestational age (AGA),
- were spontaneously breathing (extubated and not receiving any oxygen support),
- had no history of previous intubation, routinely had caffeine in their diet, and
- whose parents volunteered to participate in the study were included in the study.
Who cannot join
- Preterm infants who were <30 and >34 years postmenstrual,
- had bradycardia,
- received an analgesic 4 hours before that could affect sleep,
- had sepsis,
- congenital anomalies,
- intracranial hemorrhage,
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- hyperbilirubinemia,
- hypoglycemia,
- underwent surgery,
- received any oxygen support, or were on mechanical ventilation were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Three Stair Positioning Pillows and Positioning Materials on the Sleep-Wakefulness Status of Preterm Infants
This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.
Read the detailed description
It is known that newborns have similar brain activity in the intrauterine period and REM sleep activity, and they sleep more than adults and spend most of their sleep in the REM sleep period. Therefore, sleep quality in the newborn period is directly related to healthy development. Providing a developmentally supportive position in neonatal intensive care units (NICU) is necessary not only for neuromotor and musculoskeletal development, but also for physiological function and stability, thermal regulation, bone density, neurobehavioral organization, calmness and comfort, skin integrity, optimal musculoskeletal development, facilitation of sleep, growth and brain development. Excessive noise in the NICU, prolonged bright lights, separation from the mother, frequent invasive procedures and pain experience are among the factors that disrupt, shorten and create stress in the sleep duration of preterm babies. It is very important to support the sleep of preterm babies in the NICU in order to improve their growth and development, especially their brain development. It is known that therapeutic positions, which are one of the individualized developmental care practices, are effective on sleep.This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.
- Conditions
- Sleep
- Being tested
- Three stair position pillow group, Positioning material group
- Keywords
- preterm, infants, neonatal intensive care unit
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three stair position pillow groupOther
Preterm infants were monitored with three stair position pillows.
Positioning material groupOther
Preterm infants were monitored with positioning material pillows.
| Study group | Role | What they receive |
|---|---|---|
| Three stair position pillow group | Experimental | Three stair position pillows were used for preterm infants. Receives: Other: Three stair position pillow group |
| Positioning material group | Experimental | Positioning materials were used for preterm infants. Receives: Other: Positioning material group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Measured with an actigraphy device. Unit is minutes.
Measured: 3 hours
wakefulness
Measured with an actigraphy device. Unit is minutes.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start5 Feb 2023
- Primary completion17 Jul 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma BOZDAG, Harran University
- Investigators
- fatma bozdağ, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664749
- Sponsor's protocol ID
- HRU-BOZDAG-003
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Three Stair Positioning Pillows and Positioning Materials on the Sleep-Wakefulness Status of Preterm Infants
- ClinicalTrials.gov ID
- NCT06664749
- Acronym / sponsor ID
- HRU-BOZDAG-003
- Conditions
- Sleep
- Keywords
- preterm, infants, neonatal intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 29 Oct 2024 (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 study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.
Detailed description
It is known that newborns have similar brain activity in the intrauterine period and REM sleep activity, and they sleep more than adults and spend most of their sleep in the REM sleep period. Therefore, sleep quality in the newborn period is directly related to healthy development. Providing a developmentally supportive position in neonatal intensive care units (NICU) is necessary not only for neuromotor and musculoskeletal development, but also for physiological function and stability, thermal regulation, bone density, neurobehavioral organization, calmness and comfort, skin integrity, optimal musculoskeletal development, facilitation of sleep, growth and brain development. Excessive noise in the NICU, prolonged bright lights, separation from the mother, frequent invasive procedures and pain experience are among the factors that disrupt, shorten and create stress in the sleep duration of preterm babies. It is very important to support the sleep of preterm babies in the NICU in order to improve their growth and development, especially their brain development. It is known that therapeutic positions, which are one of the individualized developmental care practices, are effective on sleep.This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three stair position pillow group | Experimental | Other: Three stair position pillow groupThree stair position pillows were used for preterm infants. |
| Positioning material group | Experimental | Other: Positioning material groupPositioning materials were used for preterm infants. |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants who were postmenstrual age ≥30 and ≤34,
- had an appropriate weight for gestational age (AGA),
- were spontaneously breathing (extubated and not receiving any oxygen support),
- had no history of previous intubation, routinely had caffeine in their diet, and
- whose parents volunteered to participate in the study were included in the study.
Key exclusion criteria (10 listed)
- Preterm infants who were <30 and >34 years postmenstrual,
- had bradycardia,
- received an analgesic 4 hours before that could affect sleep,
- had sepsis,
- congenital anomalies,
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 |
|---|---|---|
| Three stair position pillow groupPreterm infants were monitored with three stair position pillows. | Other | Three stair position pillow group |
| Positioning material groupPreterm infants were monitored with positioning material pillows. | Other | Positioning material group |
Primary outcome
Sleep
Time frame: 3 hours
Measured with an actigraphy device. Unit is minutes.
wakefulness
Time frame: 3 hours
Measured with an actigraphy device. Unit is minutes.
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 29 Oct 2024.
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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.
fatma bozdağ principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three stair position pillow group and Positioning material group in people with Sleep, run by Harran University at 1 site in Turkey (Türkiye).
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 5 inclusion and 10 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 29 Oct 2024. 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 Turkey (Türkiye). 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?
Sleep (time frame: 3 hours). The study lists 2 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 29 Oct 2024.