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

NCT01807533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2018-08-24

No results posted yet for this study

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.

Conditions

  • Premature Birth

Interventions

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.

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Suh-Fang Jeng, Professor · School and Graduate Institute of Physical Therapy, National Taiwan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-22
Primary Completion
2017-01-10
Completion
2017-01-10

Countries

  • Taiwan

Study Locations

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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 NCT01807533 on ClinicalTrials.gov