Clinical trial NCT02533661: Effects of Family-Centered Intervention for Preterm Infants at Preschool Age
Official title: Effects of Family-Centered Intervention for Preterm Infants at Preschool Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Effectiveness
Genes
Intervention
Neurodevelopment
Prematurity
Preschool Age
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2015-08-27
Enrollment: 220
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Accumulating data on early intervention for preterm infants in Western countries have demonstrated short- to medium-term benefits on enhancing child cognitive outcome. Furthermore, the cumulative plasticity of dopamine-related genes may interact with environmental intervention in influencing a child's behavior. However, rare studies have examined the long-term effect of early intervention for preterm infants in Eastern society and whether the genetic markers interact with environmental intervention in shaping child developmental outcomes. To meet the contemporary concept of family-centered intervention and to adapt the findings of our previous studies into program design, we have developed a family-centered intervention program (FCIP) for preterm infants with very low birth weight (VLBW, birth weight \<1,500 g) in Taiwan and employed a multi-centered, randomized controlled study design to examine its short-term effects with respect to a usual care program (UCP) and its biosocial pathways.The FCIP contained ecologically pervasive child-, parent- and dyad-focused services that lasted from hospitalization until 12 months; the UCP contained child-focused services in hospitalization and phone calls after discharge. This three-year multi-centered study is therefore aimed to extend our research to examine the long-term effectiveness of FCIP on child and parent outcome compared to a usual care program (UCP) for VLBW preterm children in Taiwan at preschool age and to investigate if dopamine-related genes moderate intervention effect on child developmental outcome. A total of 275 ( 269 participants + 6 pilots) VLBW preterm infants have been enrolled and randomly assigned to the FCIP and UCP, and their buccal cells samples have been collected for typing of dopamine-related genes. All infants and families will be examined at 3 and 4 years of age for child and parent outcomes. Child outcomes will include growth, health, cognition, language, motor function, and behavioral measures; parent outcomes will consist of parental stress and quality of life measures. The long-term effect of early intervention for preterm infants will provide important information to help medical/educational professionals and public policy makers develop and assess effective intervention for Taiwanese preterm children who are at risk of developmental disorders. Furthermore, the results will help reveal the gene and intervention interaction on child developmental outcome.

Detailed description: Study Purposes:

This study is to extend our previous research to longitudinally examine the effectiveness of FCIP and UCP for VLBW preterm children in Taiwan at 3 and 4 years of age and to investigate if dopamine-related genes moderate intervention effect on child developmental outcome. Effectiveness examined will include child and parent outcomes. Child outcomes will consist of growth, health, neurodevelopment (cognition, language and motor function) and behavior. Parent outcomes will include parental stress and quality of life. The long-term effect of early intervention for preterm children from the neonatal period to preschool age will provide important information to help medical professionals and public policy makers to develop effective intervention for Taiwanese preterm children who are at risk of developmental problems. Furthermore, the genetic susceptibility theory and the cumulative genetic plasticity theory will be used to examine the relations of polymorphisms of dopamine-related genes with child development and their possible interactions with environmental intervention on child development. Over twenty dopamine genetic markers that were identified in extensive research as being associated with plasticity for neurodevelopmental functions will be examined for their individual and synergistic influences on developmental outcomes.

Participants:

Two hundred and seventy-five VLBW preterm children participating in our previous study who were born or admitted at National Taiwan University Hospital (NTUH), Mackay Memorial Hospital (MMH) and National Cheng Kung University Hospital (NCKUH) during the period of April 2012 to December 2014 will be enrolled in this study.

Methods:

All families will be contacted via phone call and mail to participate in this study. Children and their parents will be examined for the following outcomes when the children approach 3 and 4 years of age. All measures will be conducted at the Infant Motor Development Laboratory, School of Physical Therapy, National Taiwan University, and the Cognitive Electrophysiology Laboratory, Institute of Cognitive Science, National Cheng Kung University. The outcome measures in this study will consist of the primary child outcome (growth, health, neurodevelopment \[cognitive, language and motor function\] and behavior) and the secondary parent outcome (parental stress and quality of life). Child neurodevelopment will be examined using the Bayley Scales of Infant Development- 2nd edition, Bayley Scales of Infant and Toddler Development-3rd edition, Movement Assessment Battery for Children-2nd Edition, and Wechsler PreSchool and Primary Scales of Intelligence-4th Edition. Child behavior will be examined using the Children's Behavior Questionnaire, Swanson, Nolan, and Pelham Questionnaire- 4th Edition, and Child Behavior Check List/4-18. Parental stress will be assessed using the Parenting Stress Index-Long Form and quality of life will be assessed using the Chinese Version World Health Organization Quality of Life- Brief Taiwan Version. Each assessment will be delineated as follows.

Eligibility criteria: The inclusion criteria for VLBW preterm infants were:

1. birth weight less than 1,500 gram
2. gestational age lower than 37 weeks

The inclusion criteria for parents were:

1. mothers older than 18 years of age;
2. Taiwan nationality
3. absence of maternal substance abuse (alcohol or drug)
4. married or living together at delivery
5. families residing in northern or southern Taiwan.

The exclusion criteria for VLBW preterm infants were:

1. congenital abnormality
2. severe neonatal and perinatal diseases: Severe neonatal diseases refer to major neurologic abnormalities (e.g., seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage and stage IV-V retinopathy of prematurity), necrotizing enterocolitis grade II and severe cardiopulmonary disease requiring daily oxygen use at hospital discharge that may require intensive developmental intervention and therefore did not suit for our interventions.

Furthermore, infants exhibiting persistently unstable physiological conditions until 36 weeks' PMA or older, being discharged from hospital at 44 weeks' PMA or older, or developing severe neonatal diseases were early terminated.

Primary outcomes:
measure: Child: Health status
timeFrame: up to 2 years
measure: Child: Growth - weight
timeFrame: up to 2 years
measure: Child: Growth - height
timeFrame: up to 2 years
measure: Child: Growth - head circumference
timeFrame: up to 2 years
measure: Child: Neurodevelopment - Bayley Scale of Infant and Toddler Development- 2nd and 3rd Edition
timeFrame: 1 year
measure: Child: Neurodevelopment - The Wechsler Preschool and Primary Scale of Intelligence-Revised Edition
timeFrame: 1 year
measure: Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition
timeFrame: 1 year
measure: Child: Behavior - Children's Behavior Questionnaire
timeFrame: 1 year
measure: Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV
timeFrame: 1 year
measure: Child: Behavior - Child Behavior Check List/1.5-5
timeFrame: 1 year
measure: Child: Neurodevelopment - The Berry-Buktenica Developmental Test of Visual-Motor Integration
timeFrame: 1 year
Secondary outcomes:
measure: Parent: Parental stress - Parenting Stress Index/ Long Form
timeFrame: 1 year
measure: Parent: Quality of life - World Health Organization Quality of Life- Brief Taiwan Version
timeFrame: 1 year
measure: Child: Neurophysiological functions
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
name: Suh-Fang Jeng
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.