Clinical trial NCT01807533: A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
Official title: A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Environment
Gene
Intervention
Neurodevelopment
Pathways
Preterm infants
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2013-03-08
Enrollment: 275
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Child: neurodevelopment functions (cognition, language and motor)
timeFrame: 24 months of corrected age
Secondary outcomes:
measure: Change of neurodevelopment functions (motor) from baseline
timeFrame: 0 months of corrected age
measure: Child: neurodevelopment functions (behavior)
timeFrame: 24 months of corrected age
measure: Change of neurodevelopment functions (cognition, language and motor) from baseline
timeFrame: 6,12, and 24 months
measure: Parental functions and change from baseline (pressure)
timeFrame: 0, 6, 12, 18, and 24 months of corrected age
measure: Parental functions and change from baseline (Quality of Life)
timeFrame: 0, 6, 12, 18, and 24 months of corrected age
measure: Transactional functions and change from baseline
timeFrame: 6, 12, and 18 months of corrected age
measure: Transactional functions and change from baseline
timeFrame: 6 and 12 months of corrected age
measure: Transactions function: affordance
timeFrame: 18 months of corrected age
measure: Child: Medical data
timeFrame: Birth to 24 months of corrected age
measure: Child: growth data and change from baseline
timeFrame: 0, 1, 4, 6, 12, 18, and 24 months of corrected age
measure: Child: neurophysiological functions and change from baseline
timeFrame: 1 and 4 months of corrected age
measure: Child: genotyping and gene expression
timeFrame: 0 month of corrected age
measure: Parental adherence to Intervention
timeFrame: 32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Suh-Fang Jeng, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li SJ, Tsao PN, Tu YK, Hsieh WS, Yao NJ, Wu YT, Jeng SF. Cognitive and motor development in preterm children from 6 to 36 months of age: Trajectories, risk factors and predictability. Early Hum Dev. 2022 Sep;172:105634. doi: 10.1016/j.earlhumdev.2022.105634. Epub 2022 Jul 28.
citation: Yu YT, Huang WC, Hsieh WS, Chang JH, Lin CH, Hsieh S, Lu L, Yao NJ, Fan PC, Lee CL, Tu YK, Jeng SF. Family-Centered Care Enhanced Neonatal Neurophysiological Function in Preterm Infants: Randomized Controlled Trial. Phys Ther. 2019 Dec 16;99(12):1690-1702. doi: 10.1093/ptj/pzz120.