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

Terminated

• Conditions: Congenital Heart Disease

• Registration Number: NCT01291797
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Neonates with congenital heart disease are at increased risk of adverse long term neurodevelopmental outcomes, including lower mean intelligent quotients (IQs). However, it is difficult to predict with neonates are most likely to be affected and a cost effective method is needed. AEEG has been used in neonates with hypoxic-ischemic encephalopathy and abnormal sleep wake cycles have been proposed to predict poorer long term outcomes. We thus hypothesize that abnormal sleep wake cycles in neonates with congenital heart disease will correlate with poorer outcomes. In our study, we will examine the relationship between performance on a neurodevelopmental screening tool, the Dubowitz neonatal neurological screening tool, and the sleep wake cycles on AEEG both before and after cardiac repair to try and predict which neonates are at increased risk of adverse long term outcomes. We will also compare the findings of the AEEG and performance on the neurodevelopmental tool to the data gathered from neonates without cardiac disease.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abnormal sleep wake cycles on AEEG	from 24 hours of life to time of discharge home from the neonatal intensive care unit (NICU) which is on average about four weeks

Secondary Outcome Measures

Name	Time	Method
Performance on neurologic screening tools	from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Head ultrasound abnormalities	from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Seizures	from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Death	from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Inability to feed orally	from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Respiratory support requirement	from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks

Trial Locations

Locations (1)

Mount Sinai Hospital Division of Newborn Medicine; 🇺🇸 New York, New York, United States