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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01807533

Collaborator

National Health Research Institutes, Taiwan (Other)

275

Enrollment

Locations

Arms

55.7

Actual Duration (Months)

91.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Four hypotheses will be tested in this study:

The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period.
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.
Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants.
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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Behavioral: Family-centered intervention program Behavioral: Usual care intervention program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

275 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 22, 2012

Actual Primary Completion Date :

Jan 10, 2017

Actual Study Completion Date :

Jan 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Family-centered intervention program FCIP: family members were encouraged to present in all intervention sessions included 5 in-hospital intervention, 7 after-discharge interventions (0, 1, 2, 4, 6, 9, and 12 months of corrected age), and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.	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 Other Names: FCIP
Other: Usual care intervention program UCP: family members were invited to present at least one session of the 5 in-hospital intervention session. Parents and infants in the UCP group received 7 after-discharge phone calls (0, 1, 2, 4, 6, 9, and 12 months of corrected age) and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.	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. Other Names: UCP

Arm

Intervention/Treatment

Experimental: Family-centered intervention program

FCIP: family members were encouraged to present in all intervention sessions included 5 in-hospital intervention, 7 after-discharge interventions (0, 1, 2, 4, 6, 9, and 12 months of corrected age), and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.

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

Other Names:

FCIP

Other: Usual care intervention program

UCP: family members were invited to present at least one session of the 5 in-hospital intervention session. Parents and infants in the UCP group received 7 after-discharge phone calls (0, 1, 2, 4, 6, 9, and 12 months of corrected age) and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.

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.

Other Names:

UCP

Outcome Measures

Primary Outcome Measures

Child: neurodevelopment functions (cognition, language and motor) [24 months of corrected age]
Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition

Secondary Outcome Measures

Change of neurodevelopment functions (motor) from baseline [0 months of corrected age]
The Neonatal Neurobehavioral Examination-Chinese Version (NNE-C) 2. World Health Organization Quality of Life- Brief Taiwan version
Child: neurodevelopment functions (behavior) [24 months of corrected age]
Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version
Change of neurodevelopment functions (cognition, language and motor) from baseline [6,12, and 24 months]
Bayley Scales of Infant and Toddler Development - 3rd edition 2. World Health Organization Quality of Life- Brief Taiwan version
Parental functions and change from baseline (pressure) [0, 6, 12, 18, and 24 months of corrected age]
Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version
Parental functions and change from baseline (Quality of Life) [0, 6, 12, 18, and 24 months of corrected age]
World Health Organization Quality of Life- Brief Taiwan version
Transactional functions and change from baseline [6, 12, and 18 months of corrected age]
Mother-infant interaction in free play at 6, 12, and 18 months of corrected age
Transactional functions and change from baseline [6 and 12 months of corrected age]
Wakeful Position Questionnaire at 6 and 12 months of corrected age
Transactions function: affordance [18 months of corrected age]
1. Affordances in the Home Environment Motor Development- Chinese version
Child: Medical data [Birth to 24 months of corrected age]
Chart review
Child: growth data and change from baseline [0, 1, 4, 6, 12, 18, and 24 months of corrected age]
Chart review and measurement
Child: neurophysiological functions and change from baseline [1 and 4 months of corrected age]
Electroencephalogram/event-related potential
Child: genotyping and gene expression [0 month of corrected age]
Buccal cell collection
Parental adherence to Intervention [32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months]
Only assessed in FCIP group Parental motivation Goal attainment Home activity records

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 36 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.