Premature Birth
Conditions
Keywords
Environment, Gene, Intervention, Neurodevelopment, Pathways, Preterm infants
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.
Interventions
BEHAVIORALFamily-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
BEHAVIORALUsual 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
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child: neurodevelopment functions (cognition, language and motor) | 24 months of corrected age | Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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: 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 1. Parental motivation 2. Goal attainment 3. Home activity records |
| Transactions function: affordance | 18 months of corrected age | 1\. Affordances in the Home Environment Motor Development- Chinese version |
Countries
Taiwan
Outcome results
None listed