An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01567579|
Recruitment Status : Recruiting
First Posted : March 30, 2012
Last Update Posted : May 16, 2017
|Condition or disease|
|Congenital Heart Defects|
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:
- 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,
- to evaluate longitudinal changes in the trajectory of development for subjects that undergo repeated developmental and psychosocial screening,
- 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
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
- Bayley Scales of Infant and Toddler Development Third Edition [ Time Frame: every 6 months ]test of developmental skills
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567579
|Contact: Kathleen A Mussatto, PhD, RNfirstname.lastname@example.org|
|Contact: Mara C Koffarnus, MAemail@example.com|
|United States, Wisconsin|
|Children's Hospital of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Greg Anderson 414-337-7705 firstname.lastname@example.org|
|Contact: Bridget Billingsley 414-337-7454 email@example.com|
|Principal Investigator: Kathleen A Mussatto, PhD, RN|
|Principal Investigator:||Cheryl L Brosig Soto, PhD||Medical College of Wisconsin|
|Principal Investigator:||Kathleen A Mussatto, PhD, RN||Children's Hospital and Health System Foundation, Wisconsin|
|Principal Investigator:||Laurel M Bear, MD||Medical College of Wisconsin|