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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01291797
• Other study ID #: MSSM 10-0568
• Status: Terminated
• Phase: N/A
• First received: February 3, 2011
• Last updated: August 17, 2011
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
United States	Mount Sinai Hospital Division of Newborn Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Seizures		from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks	No
Secondary	Death		from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks	No
Secondary	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	No
Secondary	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	No