NCT03013023

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 28 Weeks – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The proposed study has five specific aims: 1. to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU, 2. to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU, 3. to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns, 4. to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and 5. to determine the long-term effects of the behavioral-support interventions and PITP on parent-infant interactions and infants' long-term emotional regulation and neurobehavioral outcomes.

Conditions

• Early Interventions
• Preterm Infants
• Parent-Child Relations

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-03-01
• Completion: 2017-08-01
• First posted: 2017-01-06
• Last updated: 2020-11-03