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

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Behavioral: Family-centered intervention program; Behavioral: Usual care intervention program

• Registration Number: NCT01807533
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Study Timeline

• Study Start: 2012-05-22
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Primary Completion: 2017-01-10
• Study Completion: 2017-01-10
• Status Verified: 2017-03
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family-centered intervention program	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.
Usual care intervention program	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Transactional functions and change from baseline	6 and 12 months of corrected age	Wakeful Position Questionnaire at 6 and 12 months of corrected age
Child: neurophysiological functions and change from baseline	1 and 4 months of corrected age	Electroencephalogram/event-related potential
Transactions function: affordance	18 months of corrected age	1. Affordances in the Home Environment Motor Development- Chinese version
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
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
Child: Medical data	Birth to 24 months of corrected age	Chart review
Parental adherence to Intervention	32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months	Only assessed in FCIP group; 1. Parental motivation; 2. Goal attainment; 3. Home activity records
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
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
Child: growth data and change from baseline	0, 1, 4, 6, 12, 18, and 24 months of corrected age	Chart review and measurement
Child: genotyping and gene expression	0 month of corrected age	Buccal cell collection

Trial Locations

Locations (3)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan