Clinical trial NCT01291797: Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease
Official title: Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Heart Disease
Keywords: congenital heart disease
neurodevelopmental outcome
AEEG
sleep wake cycles
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anticipated, 65 newborns with congenital heart disease and 20 newborns without congenital heart disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Abnormal sleep wake cycles on AEEG
timeFrame: 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 outcomes:
measure: Performance on neurologic screening tools
timeFrame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
measure: Head ultrasound abnormalities
timeFrame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
measure: Seizures
timeFrame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
measure: Death
timeFrame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
measure: Inability to feed orally
timeFrame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
measure: Respiratory support requirement
timeFrame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital Division of Newborn Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ian Holzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.