Status:
COMPLETED
Prenatal Effects of Congenital Heart Disease (CHD) on Neurodevelopmental Outcome
Lead Sponsor:
Columbia University
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 50 years
Brief Summary
The purpose of this study is to investigate the prenatal impact of abnormal cardiac structure on neurodevelopmental outcomes in children with congenital heart disease.
Detailed Description
Congenital heart disease (CHD) is the most common class of birth defect and is a major cause of infant and child death and morbidity, including neurodevelopmental delay. Children with severe forms of ...
Eligibility Criteria
Inclusion
- All women who present to Columbia University Medical Center between 18-24 wks gestational age with the following fetal diagnoses will be invited to participate:
- Hypoplastic Left Heart Syndrome (HLHS)
- Transposition of the Great Arteries (TGA)
- Tetralogy of Fallot (TOF)
- Lung anomalies consisting of either congenital cystic adenomatoid malformations or bronchogenic cysts
Exclusion
- Documented fetal chromosomal anomaly
- Structural brain malformations
- Evidence of placental insufficiency or Intrauterine growth retardation
- Documented hydrops fetalis or sustained cardiac arrhythmias
- Anticipated delivery at an outside hospital
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00713635
Start Date
December 1 2010
End Date
January 1 2016
Last Update
July 18 2017
Active Locations (1)
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1
Columbia University College of Physicians & Surgeons, Morgan Stanley Children's Hospital of New York
New York, New York, United States, 10032