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

This study has been terminated.
(due to inability to recruit sufficient sample size in reasonable time frame.)
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01291797
First received: February 3, 2011
Last updated: August 17, 2011
Last verified: August 2011

February 3, 2011
August 17, 2011
July 2010
June 2011   (final data collection date for primary outcome measure)
Abnormal sleep wake cycles on AEEG [ Time Frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit (NICU) which is on average about four weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01291797 on ClinicalTrials.gov Archive Site
  • Performance on neurologic screening tools [ Time Frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks ] [ Designated as safety issue: No ]
  • Head ultrasound abnormalities [ Time Frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks ] [ Designated as safety issue: No ]
  • Seizures [ Time Frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks ] [ Designated as safety issue: No ]
  • Death [ Time Frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks ] [ Designated as safety issue: No ]
  • Inability to feed orally [ Time Frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks ] [ Designated as safety issue: No ]
  • Respiratory support requirement [ Time Frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Congenital Heart Disease
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
up to 2 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01291797
MSSM 10-0568
No
Ian Holzman, MD, Principal Investigator, Mount Sinai Hospital Division of Newborn Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Ian Holzman, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP