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

National Taiwan University

Status: Completed

Conditions: Premature Birth

Treatments: Behavioral: Usual care intervention program; Behavioral: Family-centered intervention program

Study type: Interventional

Funder types: Other

Identifiers

NCT01807533

201103075RB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 275 patients

Sex: All

Ages: Under 36 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

275 participants in 2 patient groups

Family-centered intervention program

Experimental group

Description:

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.

Treatment:

Behavioral: Family-centered intervention program

Usual care intervention program

Other group

Description:

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.

Treatment:

Behavioral: Usual care intervention program