An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
Condition: Congenital Heart Defects
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      The purpose of this study is to understand how having a heart problem affects
      development,quality of life, and family life in young children and their families. Results
      for children and families with heart disease will be compared to children and families
      without heart disease. The investigators hope that this information may help us to support
      children and families better in the future. All children and families that are seen in the
      HHC Developmental Follow-Up Program will be asked if they would like to take part in this
      study. It is hypothesized that children with congenital heart disease will demonstrate
      developmental delays when compared to normative values.
    

Detailed description: 
      Research suggests that children with congenital heart disease are at higher risk for
      neurodevelopmental and psychosocial problems. Routine developmental screening and early
      intervention have been suggested as strategies to identify and ameliorate these problems. The
      purpose of this study is to describe the developmental trajectory and psychosocial
      functioning of children referred to the Herma Heart Center Developmental Follow-Up Program
      for routine developmental assessment.

      The specific aims of this project are:

        1. to summarize the results of developmental screening, quality of life, and family impact
           in subjects that have been evaluated in the HHC Developmental Follow-Up Program since
           its inception in 2007,

        2. to evaluate longitudinal changes in the trajectory of development for subjects that
           undergo repeated developmental and psychosocial screening,

        3. to characterize how subjects with congenital heart disease compare to normative data for
           the instruments utilized and samples of children with other chronic health conditions,
           and

        4. to determine what factors predict variability in developmental outcomes i.e. demographic
           and clinical variables such as gender, race, socioeconomic status, diagnosis, type of
           surgery, and length of hospitalization among others.

      Because our research and the research of others have indicated that children with Congenital
      Heart Disease (CHD) are at higher risk for neurodevelopmental and psychosocial problems, the
      Herma Heart Center Developmental Follow-Up Program was created in 2007. All infants who have
      open-heart surgery within the first 30 days of life, and all children under the age of 3
      years who have a cyanotic lesion are referred to the clinic.

      This study will utilize both retrospective chart review and prospective collection of data
      from new subjects entering the program.

      No additional procedures are required to participate in the research study. Participation in
      the research study involves granting permission for the research team to systematically
      analyze the data obtained during the HHC Developmental Follow-Up Program clinic visits that a
      child participates in and to aggregate these data with all subjects that have received these
      follow-up assessments.

      A sample size of 1000 subjects is needed to ensure adequate power to detect medium effect
      sizes for the multiple outcome measures that are proposed (assuming p = .05 and power = .80).
      Therefore, recruitment for the study will continue until a sample size of 1000 subjects is
      reached. Estimated recruitment duration is 7 years.

      There are no anticipated risks related to participation in this study.

      Descriptive analyses will be conducted to summarize characteristics of the sample and to
      determine the frequency of developmental/behavioral/emotional problems among children in the
      present sample. Correlation and regression analyses will be conducted to examine the
      relationships among demographic, clinical, and outcome variables. For children with multiple
      visits, longitudinal changes and the pattern of developmental trajectory for children with
      congenital heart disease will be examined.

      Results may point to possible areas for intervention to improve child and family psychosocial
      outcomes.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who have had congenital heart surgery, before the age of 1.
      
Keywords: congenital heart defects