Effects of Family-Centered Intervention for Preterm Infants at Preschool Age
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Intervention name(s): Family-centered intervention program
Intervention type(s): Other
Intervention description(s): This program will include in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention will emphasize modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention will consist 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
Other intervention name(s): early intervention program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Effectiveness; Genes; Intervention; Neurodevelopment; Prematurity; Preschool Age