Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Abnormal sleep wake cycles on AEEG
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Abnormal sleep wake cycles on AEEG
时间窗: from 24 hours of life to time of discharge home from the neonatal intensive care unit (NICU) which is on average about four weeks
次要结局
- 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)
- 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)