NCT01807533

A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 36 Weeks
• Healthy volunteers: Not accepted

Summary

Four hypotheses will be tested in this study: 1. The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period. 2. The intervention group shows greater changes in early neurophysiological brain functions and transactions within the family that lead to better neurodevelopmental outcomes than the control group. 3. Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants. 4. Very low birth weight preterm infants carrying more genetic plasticity in the dopamine-related genes may benefit more from the interventions than those carrying less genetic plasticity.

Detailed description

A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group. Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family). The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development. In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses. The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.

Conditions

• Premature Birth

Interventions

Type	Name	Description
BEHAVIORAL	Family-centered intervention program	This program was in-hospital intervention, after-discharge intervention, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The 7-session after-discharge intervention consisted of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education
BEHAVIORAL	Usual care intervention program	This program was in-hospital intervention, after-discharge consultation, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The after-discharge service was provided 7-phone calls for the general health consultation.

Timeline

• Start date: 2012-05-22
• Primary completion: 2017-01-10
• Completion: 2017-01-10
• First posted: 2013-03-08
• Last updated: 2018-08-24

Locations

3 sites across 1 country: Taiwan