Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01567579
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2012-03-28
Brief Title:
An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to understand how having a heart problem affects developmentquality 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 ie 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 developmentalbehavioralemotional 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
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 ie 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 developmentalbehavioralemotional 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None