NCT03010891

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

December 29, 2016

Last Update Submit

October 31, 2020

Conditions

Preterm InfantsStress

Keywords

Preterm infantStressSalivary DHEASalivary cortisolActigraphy

Outcome Measures

Primary Outcomes (1)

  • Preterm infant salivary cortisol

    Accessed by salivary cortisol ELISA kit

    up to 3 months

Secondary Outcomes (4)

  • Preterm infant sleep

    up to 3 months

  • Preterm infant physiological signals of infant distress

    up to 3 months

  • All preterm infants' physical activity are accessed by using Actigraphy

    up to 3 months

  • Preterm infant salivary DHEA levels

    up to 3 months

Study Arms (2)

control condition

ACTIVE COMPARATOR

Preterm infants in the control condition will receive only usual NICU care, plus positioning and gentle touch during intrusive procedures.

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.

Behavioral: The bundle of supportive interventions

Interventions

The bundle of supportive interventionsBEHAVIORAL

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

experimental condition
Usual NICU careBEHAVIORAL

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

control condition

Eligibility Criteria

Age28 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (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

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jen-Jiuan Liaw, Professor

    Professor, School of Nursing, 1National Defense Medical Center, Taipei, Taiwan, ROC.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator, National Defense Medical Center, Taiwan

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 5, 2017

Study Start

March 1, 2016

Primary Completion

August 1, 2017

Study Completion

May 1, 2018

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share