NCT01567579

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
928

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

12 years

First QC Date

March 28, 2012

Last Update Submit

November 18, 2021

Conditions

Congenital Heart Defects

Keywords

congenital heart defects

Outcome Measures

Primary Outcomes (1)

  • Bayley Scales of Infant and Toddler Development Third Edition

    test of developmental skills

    every 6 months

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Non-English and Non-Spanish speaking families
  • Children with extremely complex co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (6)

  • 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.

    PMID: 21718458RESULT

  • Mussatto 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.

    PMID: 24488746RESULT

  • Mussatto 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.

    PMID: 26304667RESULT

  • Brosig 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.

    PMID: 28081891RESULT

  • Brosig 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.

    PMID: 30191663RESULT

  • Jilek 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.

    PMID: 34548125RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Cheryl L Brosig, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

  • Laurel M Bear, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Pediatrics, Cardiology

Study Record Dates

First Submitted

March 28, 2012

First Posted

March 30, 2012

Study Start

September 1, 2009

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

US(1)