An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease

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.

Inclusion Criteria:

- Referred to the Herma Heart Center (HHC)Developmental Follow-Up Clinic for assessment.

Exclusion Criteria:

- Non-English and Non-Spanish speaking families

- Children with extremely complex co-morbidities