Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease

Stopped early

Conditions studied: Congenital Heart Disease

In brief

This study aims to examine performance on a neurological screening test, the Dubowitz, and sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with congenital heart disease (CHD) as a way to potentially predict longterm motor outcome. It will compare the results of these studies to neonates without CHD.

Key facts

Study ID

NCT01291797

Run by

Icahn School of Medicine at Mount Sinai

People needed

4

Starts

2010-07-01

Expected to finish

2011-06-01

Last updated by the study team

2011-08-19

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newborn with cardiac anomaly requiring surgical intervention or a newborn that is in NICU for at least 24 hours for monitoring
• If newborn has congenital cardiac anomaly, cardiac repair must be performed at Mount Sinai Hospital
• If newborn has congenital cardiac anomaly, he/she must be managed pre-operatively for at least 24 hours at Mount Sinai Hospital
• If newborn has congenital cardiac anomaly, he/she must be managed post-operatively at Mount Sinai Hospital for at least 72 hours

You may not qualify if…

• Newborns with previously known anomalies other than cardiac
• Chromosomal abnormalities other than 22Q, that might have long-term neurodevelopmental implications
• Diagnosis of hypoxic-ischemic encephalopathy
• Metabolic disorder
• Other genetic disorders

Where it is running

• Mount Sinai Hospital Division of Newborn Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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