Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
due to inability to recruit sufficient sample size in reasonable time frame.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Anticipated, 65 newborns with congenital heart disease and 20 newborns without congenital heart disease
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ian Holzman, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital Division of Newborn Medicine | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18249516 | Background | 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. | |
| 16325677 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 11060529 | 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. |
| 12563063 | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |