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

This study is currently recruiting participants.
Verified July 2013 by Medical College of Wisconsin
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Cheryl Brosig, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01567579
First received: March 28, 2012
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition
Congenital Heart Defects

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Bayley Scales of Infant and Toddler Development Third Edition [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
    test of developmental skills


Estimated Enrollment: 1000
Study Start Date: January 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children who have had congenital heart surgery, before the age of 1.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567579

Contacts
Contact: Kathleen A Mussatto, PhD, RN 414-266-2073 kmussatto@chw.org
Contact: Mara C Koffarnus, BS 414-266-4758 mkoffarnus@chw.org

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Greg Anderson    414-337-7705    ganderson@chw.org   
Contact: Bridget Billingsley    414-337-7454    bbillingsley@chw.org   
Principal Investigator: Kathleen A Mussatto, PhD, RN         
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
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
  More Information

No publications provided

Responsible Party: Cheryl Brosig, Associate Professor, Pediatrics, Cardiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01567579     History of Changes
Other Study ID Numbers: CHW 09/98, GC 896
Study First Received: March 28, 2012
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
congenital heart defects

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 22, 2014