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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Congenital Heart Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates with congenital heart disease<br>The case group will consist of newborns born between 32 and 41 weeks gestation diagnosed with a congenital cardiac anomaly requiring surgical repair during their hospitalization and managed in the Mount Sinai Neonatal Intensive Care Unit. The control arm will include newborns born between 32 and 41 weeks without congenital cardiac anomalies. Both groups will undergo a neurological screening assessment and receive an AEEG to look at sleep wake cycles. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart disease, neurodevelopmental outcome, AEEG, sleep wake cycles