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Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being

NCT03013023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-11-03

No results posted yet for this study

Summary

This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.

Conditions

  • Early Interventions
  • Preterm Infants
  • Parent-Child Relations

Interventions

BEHAVIORAL

BS

NNS, FT, positional support, and oral sucrose feeding

BEHAVIORAL

Routine care

Routine NICU care

BEHAVIORAL

PITP

Parents will learn to regulate infant responses while implementing caregiving activities.

BEHAVIORAL

BS+PITP

Parents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures.

Sponsors & Collaborators

  • Ministry of Science and Technology, Taiwan

    collaborator OTHER_GOV

  • National Defense Medical Center, Taiwan

    lead OTHER

Principal Investigators

  • Jen-Jiuan Liaw, Professor · Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-03-31
Completion
2017-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03013023 on ClinicalTrials.gov