Preterm InfantsNCT03010891
Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes During Invasive Procedures
A study testing The bundle of supportive interventions and Usual NICU care in people with Preterm Infants and Stress, run by National Defense Medical Center, Taiwan.
Trial summary
The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the… Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Preterm Infants, Stress
- What is being tested?
- The bundle of supportive interventions and Usual NICU care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2018
- 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
- No healthy volunteers
- Child
Who may be able to join
- (1) gestational age (GA) > 28 weeks and < 37 weeks
- (2) birth weight < 2100g
- (3) stable condition (score < 22 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity)
- (4) parents can speak, read and write Chinese
- (5) parents have no history of drug/alcohol abuse
- (6) parents agree to participate
Who cannot join
- (1) congenital anomalies
- (2) neurologic impairment including convulsion, intraventricular hemorrhage > grade II or periventricular leukomalacia
- (3) documented congenital or nosocomial (infection acquired at hospital after birth) sepsis
- (4) surgery
- (5) severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs
About this study
Official title: Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes
The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the relationships among preterm infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep, and physical activity. This randomized controlled trial will adopt a longitudinal repeated-measures design to examine the effects of bundled supportive interventions on preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant distress [using bedside electrocardiographic monitors]), sleep and physical activity (using ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants' biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.
Read the detailed description
Background and purpose: Preterm infants need to receive intensive care in a neonatal intensive care unit (NICU) to survive, but this care exposes them to painful procedures and a stressful environment. Repeated, painful/stressful stimuli can disturb infants' sleep, change their physiological indicators, and affect their developing brain and organs, possibly resulting in negative, long-lasting developmental consequences. Therefore, NICU clinicians caring for these vulnerable infants have two important goals: to provide early interventions to minimize preterm infants' stress/pain and to improve their sleep and physical activity. The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the relationships among preterm infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep, and physical activity.
Methods: This randomized controlled trial will adopt a longitudinal repeated-measures design to examine the effects of bundled supportive interventions on preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant distress [using bedside electrocardiographic monitors]), sleep and physical activity (using ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants' biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.
Expected outcomes: The study will fill a gap in knowledge about the effects of bundled supportive interventions on preterm infants' stress reactivity, sleep, and physical activity during hospitalization. This unique combination of physiological measurements of preterm infants' stress parameters and longitudinal design will provide results for establishing evidence-based clinical guidelines to provide atraumatic care to this population during intrusive procedures. Investigators also expect that bundling supportive interventions will minimize preterm infants' pain/stress as well as improve their sleep and physical activity. In the long term, the study results may help reduce the morbidity and complications due to preterm birth, save medical costs in neonatal care, and promote these infants' health and future developmental outcomes.
- Conditions
- Preterm Infants, Stress
- Being tested
- The bundle of supportive interventions, Usual NICU care
- Keywords
- Preterm infant, Stress, Salivary DHEA, Salivary cortisol, Actigraphy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The bundle of supportive interventionsBehavioural
usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC > 45 minutes
Usual NICU careBehavioural
usual NICU care + positioning + gentle touch +routine KMC < 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| control condition | Active comparator | Preterm infants in the control condition will receive only usual NICU care, plus positioning and gentle touch during intrusive procedures. Receives: Behavioral: Usual NICU care |
| experimental condition | Experimental | The bundle of supportive interventions will be designed to alleviate preterm infants' stress/pain from birth to discharge from the hospital NICU. Receives: Behavioral: The bundle of supportive interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm infant salivary cortisol
Accessed by salivary cortisol ELISA kit
Measured: up to 3 months
Secondary outcomes (4)
Preterm infant sleep
Accessed by Actigraphy
Measured: up to 3 months
Preterm infant physiological signals of infant distress
Accessed by bedside electrocardiographic monitor
Measured: up to 3 months
All preterm infants' physical activity are accessed by using Actigraphy
Accessed by Actigraphy
Measured: up to 3 months
Preterm infant salivary DHEA levels
Accessed by salivary DHEA ELISA kit
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startMar 2016
- Primary completionAug 2017
- Study completionMay 2018
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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Hsiang-Yun Lan, National Defense Medical Center, Taiwan
- Investigators
- Jen-Jiuan Liaw, Professor, Study chair, Professor, School of Nursing, 1National Defense Medical Center, Taipei, Taiwan, ROC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010891
- Sponsor's protocol ID
- 2-104-05-157
- Status last verified
- Oct 2020
- First submitted
- 29 Dec 2016
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes
- ClinicalTrials.gov ID
- NCT03010891
- Acronym / sponsor ID
- 2-104-05-157
- Conditions
- Preterm Infants, Stress
- Keywords
- Preterm infant, Stress, Salivary DHEA, Salivary cortisol, Actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Mar 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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.
The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the relationships among preterm infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep, and physical activity. This randomized controlled trial will adopt a longitudinal repeated-measures design to examine the effects of bundled supportive interventions on preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant distress [using bedside electrocardiographic monitors]), sleep and physical activity (using ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants' biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.
Detailed description
Background and purpose: Preterm infants need to receive intensive care in a neonatal intensive care unit (NICU) to survive, but this care exposes them to painful procedures and a stressful environment. Repeated, painful/stressful stimuli can disturb infants' sleep, change their physiological indicators, and affect their developing brain and organs, possibly resulting in negative, long-lasting developmental consequences. Therefore, NICU clinicians caring for these vulnerable infants have two important goals: to provide early interventions to minimize preterm infants' stress/pain and to improve their sleep and physical activity. The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the relationships among preterm infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep, and physical activity.
Methods: This randomized controlled trial will adopt a longitudinal repeated-measures design to examine the effects of bundled supportive interventions on preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant distress [using bedside electrocardiographic monitors]), sleep and physical activity (using ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants' biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.
Expected outcomes: The study will fill a gap in knowledge about the effects of bundled supportive interventions on preterm infants' stress reactivity, sleep, and physical activity during hospitalization. This unique combination of physiological measurements of preterm infants' stress parameters and longitudinal design will provide results for establishing evidence-based clinical guidelines to provide atraumatic care to this population during intrusive procedures. Investigators also expect that bundling supportive interventions will minimize preterm infants' pain/stress as well as improve their sleep and physical activity. In the long term, the study results may help reduce the morbidity and complications due to preterm birth, save medical costs in neonatal care, and promote these infants' health and future developmental outcomes.
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 |
|---|---|---|
| control condition | Active comparator | Behavioral: Usual NICU carePreterm infants in the control condition will receive only usual NICU care, plus positioning and gentle touch during intrusive procedures. |
| experimental condition | Experimental | Behavioral: The bundle of supportive interventionsThe bundle of supportive interventions will be designed to alleviate preterm infants' stress/pain from birth to discharge from the hospital NICU. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- (1) gestational age (GA) > 28 weeks and < 37 weeks
- (2) birth weight < 2100g
- (3) stable condition (score < 22 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity)
- (4) parents can speak, read and write Chinese
- (5) parents have no history of drug/alcohol abuse
Key exclusion criteria (5 listed)
- (1) congenital anomalies
- (2) neurologic impairment including convulsion, intraventricular hemorrhage > grade II or periventricular leukomalacia
- (3) documented congenital or nosocomial (infection acquired at hospital after birth) sepsis
- (4) surgery
- (5) severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs
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 |
|---|---|---|
| The bundle of supportive interventionsusual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC > 45 minutes | Behavioural | experimental condition |
| Usual NICU careusual NICU care + positioning + gentle touch +routine KMC < 20 minutes | Behavioural | control condition |
Primary outcome
Preterm infant salivary cortisol
Time frame: up to 3 months
Accessed by salivary cortisol ELISA kit
4 secondary outcomes
Preterm infant sleep
Time frame: up to 3 months
Preterm infant physiological signals of infant distress
Time frame: up to 3 months
All preterm infants' physical activity are accessed by using Actigraphy
Time frame: up to 3 months
Preterm infant salivary DHEA levels
Time frame: up to 3 months
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 3 Nov 2020.
- 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.
Jen-Jiuan Liaw, Professor study chair
Professor, School of Nursing, 1National Defense Medical Center, Taipei, Taiwan, ROC.
Questions about this trial
What is this clinical trial studying?
A study testing The bundle of supportive interventions and Usual NICU care in people with Preterm Infants and Stress, run by National Defense Medical Center, 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 6 inclusion and 5 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 infant salivary cortisol (time frame: up to 3 months). 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 3 Nov 2020.