Congenital Heart DefectsNCT01567579
An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
An observational study of Congenital Heart Defects, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Congenital Heart Defects
- How many people
- 928 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who have had congenital heart surgery, before the age of 1.
Who may be able to join
- Referred to the Herma Heart Center (HHC)Developmental Follow-Up Clinic for assessment.
Who cannot join
- Non-English and Non-Spanish speaking families
- Children with extremely complex co-morbidities
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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.
Read the 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:
- 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.
- Conditions
- Congenital Heart Defects
- Keywords
- congenital heart defects
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development Third Edition
test of developmental skills
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 928 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Cheryl Brosig, Medical College of Wisconsin
- Investigators
- Cheryl L Brosig, PhD, Principal investigator, Medical College of WisconsinLaurel M Bear, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567579
- Sponsor's protocol ID
- CHW 09/98, GC 896
- Status last verified
- Nov 2021
- First submitted
- 28 Mar 2012
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Soto CB, Olude O, Hoffmann RG, Bear L, Chin A, Dasgupta M, Mussatto K. Implementation of a routine developmental follow-up program for children with congenital heart disease: early results. Congenit Heart Dis. 2011 Sep-Oct;6(5):451-60. doi: 10.1111/j.1747-0803.2011.00546.x. Epub 2011 Jul 1.
PubMed 21718458Mussatto KA, Hoffmann RG, Hoffman GM, Tweddell JS, Bear L, Cao Y, Brosig C. Risk and prevalence of developmental delay in young children with congenital heart disease. Pediatrics. 2014 Mar;133(3):e570-7. doi: 10.1542/peds.2013-2309. Epub 2014 Feb 2.
PubMed 24488746Mussatto KA, Hoffmann R, Hoffman G, Tweddell JS, Bear L, Cao Y, Tanem J, Brosig C. Risk Factors for Abnormal Developmental Trajectories in Young Children With Congenital Heart Disease. Circulation. 2015 Aug 25;132(8):755-61. doi: 10.1161/CIRCULATIONAHA.114.014521.
PubMed 26304667Brosig CL, Bear L, Allen S, Hoffmann RG, Pan A, Frommelt M, Mussatto KA. Preschool Neurodevelopmental Outcomes in Children with Congenital Heart Disease. J Pediatr. 2017 Apr;183:80-86.e1. doi: 10.1016/j.jpeds.2016.12.044. Epub 2017 Jan 9.
PubMed 28081891Brosig CL, Bear L, Allen S, Simpson P, Zhang L, Frommelt M, Mussatto KA. Neurodevelopmental outcomes at 2 and 4 years in children with congenital heart disease. Congenit Heart Dis. 2018 Sep;13(5):700-705. doi: 10.1111/chd.12632. Epub 2018 Sep 6.
PubMed 30191663Jilek E, Shields A, Zhang L, Simpson P, Bear L, Martins SA, Mussatto KA, Brosig CL. Predictors of behavioural and emotional outcomes in toddlers with congenital heart disease. Cardiol Young. 2022 Aug;32(8):1216-1221. doi: 10.1017/S1047951121003942. Epub 2021 Sep 22.
PubMed 34548125
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01567579
- Acronym / sponsor ID
- CHW 09/98, GC 896
- Conditions
- Congenital Heart Defects
- Keywords
- congenital heart defects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 928 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Sep 2009 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who have had congenital heart surgery, before the age of 1.
Key inclusion criteria (1 listed)
- Referred to the Herma Heart Center (HHC)Developmental Follow-Up Clinic for assessment.
Key exclusion criteria (2 listed)
- Non-English and Non-Spanish speaking families
- Children with extremely complex co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bayley Scales of Infant and Toddler Development Third Edition
Time frame: every 6 months
test of developmental skills
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Results publication: PubMed 21718458Soto CB, Olude O, Hoffmann RG, Bear L, Chin A, Dasgupta M, Mussatto K. Implementation of a routine developmental follow-up program for children with congenital heart disease: early results. Congenit Heart Dis. 2011 Sep-Oct;6(5):451-60. doi: 10.1111/j.1747-0803.2011.00546.x. Epub 2011 Jul 1.
- Results publication: PubMed 24488746Mussatto KA, Hoffmann RG, Hoffman GM, Tweddell JS, Bear L, Cao Y, Brosig C. Risk and prevalence of developmental delay in young children with congenital heart disease. Pediatrics. 2014 Mar;133(3):e570-7. doi: 10.1542/peds.2013-2309. Epub 2014 Feb 2.
- Results publication: PubMed 26304667Mussatto KA, Hoffmann R, Hoffman G, Tweddell JS, Bear L, Cao Y, Tanem J, Brosig C. Risk Factors for Abnormal Developmental Trajectories in Young Children With Congenital Heart Disease. Circulation. 2015 Aug 25;132(8):755-61. doi: 10.1161/CIRCULATIONAHA.114.014521.
- Results publication: PubMed 28081891Brosig CL, Bear L, Allen S, Hoffmann RG, Pan A, Frommelt M, Mussatto KA. Preschool Neurodevelopmental Outcomes in Children with Congenital Heart Disease. J Pediatr. 2017 Apr;183:80-86.e1. doi: 10.1016/j.jpeds.2016.12.044. Epub 2017 Jan 9.
- Results publication: PubMed 30191663Brosig CL, Bear L, Allen S, Simpson P, Zhang L, Frommelt M, Mussatto KA. Neurodevelopmental outcomes at 2 and 4 years in children with congenital heart disease. Congenit Heart Dis. 2018 Sep;13(5):700-705. doi: 10.1111/chd.12632. Epub 2018 Sep 6.
- Results publication: PubMed 34548125Jilek E, Shields A, Zhang L, Simpson P, Bear L, Martins SA, Mussatto KA, Brosig CL. Predictors of behavioural and emotional outcomes in toddlers with congenital heart disease. Cardiol Young. 2022 Aug;32(8):1216-1221. doi: 10.1017/S1047951121003942. Epub 2021 Sep 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl L Brosig, PhD principal investigator
Medical College of Wisconsin
Laurel M Bear, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Defects, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant and Toddler Development Third Edition (time frame: every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01567579, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.