A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in c-Flow3310-P following routine maneuvers
研究概览
简要总结
Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain malformations. Previous studies of cerebral MRI in infants with congenital heart defects showed that in 20-40% of cases there was preoperative brain injury and post operative with the same incidence. These findings are strongly associated with early and long-term neurodevelopmental injury.
There is a necessity for a non invasive device who will monitor the cerebral blood flow during the hospitalization prior and post the cardiac defect repair surgery.
The previous modal of the study device has been cleared for marketing by the FDA (k150268).
The main goal of this study is to demonstrate that the new design of Ornim's c-FLOW 3310-P is easy to operate and effective in monitoring changes in cerebral blood flow in neonates as demonstrated in adults.
详细描述
55 eligible neonates whom have been deemed as candidates for a cardiac surgery will be enroll to the study.
At the first phase, 10 neonates will be monitored. After the investigator has assessed the patient as eligible for the study and consent will be received by the parents, the subject will be provided with a study enrollment number.
All clinical assessments routinely preformed as per standard of care during all hospitalization, such as hemodynamic continues parameters, discreet samples will be documented in the medical records, and later on the requested assessments will be recorded in the designated Case Report Form.
Monitoring will be performed a day prior to the repair surgery, following the surgery at the same day and one and two days after, for 3 hours per day.
Additional standard of care parameters will be collected :Heart rate, Mean Arterial Blood Pressure, Saturation, Ventilator rate, Medications, Blood gases ( blood tests), Echocardiogram, pre-surgery Head US,. additional examination will be performed intended for the study: two post surgery Head US, S100B biomarker for brain injury and Neurological examinations prior and 7 days post- surgery( By standardized questionnaires).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mutual parents' consent (outstanding exceptional cases who approved by the EC)
- •Born at gestational age of more than 34+6/7 weeks
- •Cardiac surgery between 0- 4 weeks of age
- •Head circumference >= 31 cm
排除标准
- •Patient with implants located in the intended area of the c-FLOW 3310-P sensor location.
- •Laceration of scalp injury at the intended area of the c-FLOW 3310-P sensors
- •Known brain malformation
- •Hydrocephalus
- •Resuscitation between the time of surgery and neurological outcome assessment
结局指标
主要结局
Change in c-Flow3310-P following routine maneuvers
时间窗: 3 hours monitoring per day, for 4 days
Changes will be measured following routine maneuvers such as suction, leg lifting, Blood sample, changing position, feeding, presence of feeding tube etc. Change= (CFI(manipulation)- CFI(baseline))- CFI(baseline)
次要结局
- The correlation between Auto-regulation index and Neurological outcomes(3 hours monitoring per day, for 4 days)