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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Behavioral: Family-centered intervention program
* Behavioral: Usual care intervention program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family-centered intervention program<br>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<br>* 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<br>* Other names: FCIP;|
| Other: Usual care intervention program<br>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<br>* 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.<br>* Other names: UCP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child: neurodevelopment functions (cognition, language and motor) | Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition | 24 months of corrected age | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Environment, Gene, Intervention, Neurodevelopment, Pathways, Preterm infants