Prenatal Effects of Congenital Heart Disease (CHD) on Neurodevelopmental Outcome

NCT00713635 | Completed

• 1 other identifier: AAAD1879
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental scores as measured by the Bayley Scales of Infant Development

  18 months of age

Secondary Outcomes (5)

• Neurologic Function as defined by neonatal electroencephalographic power and coherence as measured by a neonatal high-density EEG

  Neonatal EEG within 72 hours of birth

• Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)

  Fetal assessment between 18-24 wk GA

• Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)

  Fetal assessment between 28-32 wk GA

• Neurologic Function as defined by fetal and neonatal autonomic nervous system assessments (fetal heart rate variability and movement coupling and neonatal tilt test)

  Fetal assessment between 34-38 wk GA

• Neurologic Function as defined by neonatal electroencephalographic power and coherence as measured by a neonatal high-density EEG

  Neonatal EEG at 1 month of age

Study Arms (4)

1

Fetuses and neonates with congenital heart disease consisting of hypoplastic left heart syndrome (HLHS)

2

Fetuses and neonates with congenital heart disease consisting of transposition of the great arteries (TGA)

3

Fetuses and neonates with congenital heart disease consisting of tetralogy of fallot

4

Fetuses and neonates with lung masses but without congenital heart disease will serve as a control group

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will consist of mothers and infants referred to the Morgan Stanley Children's Hospital of New York-Presbyterian for evaluation of complex congenital heart disease consisting of: 1) single ventricle variant, such as hypoplastic left heart (HLHS); 2) Tetralogy of Fallot; 3) Transposition of the Great Vessels, and 4)Lung anomalies. Investigators anticipate that 24 mothers and 24 fetuses/infants will be enrolled during the period of study. This will give the study team a total of 24 women-fetus/infant dyads or 48 subjects total (if one counts the mother and the fetus/infant separately).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University College of Physicians & Surgeons, Morgan Stanley Children's Hospital of New York

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ismee A Williams, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: December 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2016
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

US (1)