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

NCT01291797 | Terminated

• 1 other identifier: MSSM 10-0568
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

congenital heart disease; neurodevelopmental outcome; AEEG; sleep wake cycles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital Division of Newborn Medicine

New York, New York, 10029, United States

Location

Related Publications (4)

• 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.

  PMID: 18249516 BACKGROUND

• 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.

  PMID: 16325677 BACKGROUND

• 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.

  PMID: 11060529 BACKGROUND

• 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.

  PMID: 12563063 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ian Holzman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 8, 2011
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 19, 2011

Record last verified: 2011-08

Locations

US (1)