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

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.

Study Overview

• Status: Terminated
• Conditions: Congenital Heart Disease

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 Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital Division of Newborn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Anticipated, 65 newborns with congenital heart disease and 20 newborns without congenital heart disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Neonates with congenital heart disease; 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?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Ian Holzman, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
• Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.
• Massaro AN, El-Dib M, Glass P, Aly H. Factors associated with adverse neurodevelopmental outcomes in infants with congenital heart disease. Brain Dev. 2008 Aug;30(7):437-46. doi: 10.1016/j.braindev.2007.12.013. Epub 2008 Feb 4.
• Brown MD, Wernovsky G, Mussatto KA, Berger S. Long-term and developmental outcomes of children with complex congenital heart disease. Clin Perinatol. 2005 Dec;32(4):1043-57, xi. doi: 10.1016/j.clp.2005.09.008.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Estimate): August 19, 2011
• Last Update Submitted That Met QC Criteria: August 17, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: congenital heart disease; neurodevelopmental outcome; AEEG; sleep wake cycles
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: MSSM 10-0568