Overview

This trial is active, not recruiting.

Condition premature birth
Treatment family-centered intervention program
Phase phase 2
Sponsor National Taiwan University Hospital
Collaborator National Health Research Institutes, Taiwan
Start date May 2012
End date December 2016
Trial size 250 participants
Trial identifier NCT01807533, 201103075RB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
family-centered intervention program early intervention program
This program will include in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention will emphasize modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention will consist 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
(No Intervention)

Primary Outcomes

Measure
Child: Medical and growth data
time frame: 0 month of corrected age
Child: Change of medical and growth from baseline; Neurophysiological functions
time frame: 1 month of corrected age
Child: Change of medical and growth from baseline; Change of neurophysiological functions from baseline
time frame: 4 months of corrected age
Child: Change of medical and growth from baseline; Neurodevelopment functions (cognition, language, motor)
time frame: 6 months of corrected age
Child: Change of medical and growth from baseline; Change of neurodevelopment functions (cognition, language, motor) from baseline
time frame: 12 months of corrected age
Child: Change of medical and growth from baseline
time frame: 18 months of corrected age
Child: Change of medical and growth from baseline; Change of neurodevelopment functions (cognition, language, motor) from baseline; Behavioral function
time frame: 24 months of corrected age

Secondary Outcomes

Measure
Parent function
time frame: 0 month of corrected age
Change of parent function from baseline
time frame: 6 months of corrected age
Change of parent function from baseline
time frame: 12 months of corrected age
Change of parent function from baseline
time frame: 18 months of corrected age
Change of parent function from baseline
time frame: 24 months of corrected age
Transactions function
time frame: 6 months of corrected age
Change of transactions function from baseline
time frame: 12 months of corrected age
Change of transactions function from baseline
time frame: 18 months of corrected age

Eligibility Criteria

Male or female participants up to 7 days old.

Inclusion Criteria: - birth body weight < 1500 grams - gestational age < 37 weeks - parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi Exclusion Criteria: - severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC) - congenital or chromosome abnormality - mother < 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol and drug) Terminated Criteria: - diagnosis of brain injury (e.g., PVL, stage IV ROP or greater) - severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge - hospital discharge beyond 44 weeks' post-menstrual age.

Additional Information

Official title A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
Principal investigator Suh-Fang Jeng, Professor
Description A total of 250 VLBW preterm infants will be prospectively recruited at three medical centers in northern and southern Taiwan and will be randomly assigned to the FCIP or UCP group. Outcome assessments will include primary (child medical, growth and development) and secondary measures (parent and transactions within the family). The neurophysiological and transactions data will be examined for whether they mediate intervention effects on child development. In addition, these infants and 153 VLBW preterm infants in our prior intervention study will be collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensori-motor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses. The polymorphisms of dopamine-related genes will be examined for potential moderating influence on the effects of the intervention for child development.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.