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Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes During Invasive Procedures

Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03010891
Enrollment
66
Registered
2017-01-05
Start date
2016-03-31
Completion date
2018-05-31
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants, Stress

Keywords

Preterm infant, Stress, Salivary DHEA, Salivary cortisol, Actigraphy

Brief 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 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.

Interventions

BEHAVIORALThe bundle of supportive interventions

usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC \> 45 minutes

BEHAVIORALUsual NICU care

usual NICU care + positioning + gentle touch +routine KMC \< 20 minutes

Sponsors

Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
National Defense Medical Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 37 Weeks
Healthy volunteers
No

Inclusion criteria

* (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

Exclusion criteria

* (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

Design outcomes

Primary

MeasureTime frameDescription
Preterm infant salivary cortisolup to 3 monthsAccessed by salivary cortisol ELISA kit

Secondary

MeasureTime frameDescription
Preterm infant sleepup to 3 monthsAccessed by Actigraphy
Preterm infant physiological signals of infant distressup to 3 monthsAccessed by bedside electrocardiographic monitor
All preterm infants' physical activity are accessed by using Actigraphyup to 3 monthsAccessed by Actigraphy
Preterm infant salivary DHEA levelsup to 3 monthsAccessed by salivary DHEA ELISA kit

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026