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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Preterm Infants
• Intervention / Treatment: Behavioral: Usual NICU care; Behavioral: The bundle of supportive interventions

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control condition; Preterm infants in the control condition will receive only usual NICU care, plus positioning and gentle touch during intrusive procedures.	Behavioral: Usual NICU care; usual NICU care + positioning + gentle touch +routine KMC < 20 minutes
Experimental: experimental condition; The bundle of supportive interventions will be designed to alleviate preterm infants' stress/pain from birth to discharge from the hospital NICU.	Behavioral: The bundle of supportive interventions; usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC > 45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm infant salivary cortisol	Accessed by salivary cortisol ELISA kit	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm infant sleep	Accessed by Actigraphy	up to 3 months
Preterm infant physiological signals of infant distress	Accessed by bedside electrocardiographic monitor	up to 3 months
All preterm infants' physical activity are accessed by using Actigraphy	Accessed by Actigraphy	up to 3 months
Preterm infant salivary DHEA levels	Accessed by salivary DHEA ELISA kit	up to 3 months

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Study Chair: Jen-Jiuan Liaw, Professor, Professor, School of Nursing, 1National Defense Medical Center, Taipei, Taiwan, ROC.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 31, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Stress; Preterm infant; Salivary DHEA; Salivary cortisol; Actigraphy
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2-104-05-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No