Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Hemorrhage Resorption Rate
研究概览
简要总结
The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers' experience with the study intervention. A complete list of objectives and aims are listed under "Objectives". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW/cm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.
排除标准
- •neonates without IVH grade 3/4 or older than 1 month.
研究组 & 干预措施
Non-blinded, open label experimental arm
The experimental arm will be administered treated with the study device. It will be 10 mW/cm^2 of 650nm laser through use of a novel laser device given for 5 minutes twice daily for 12 days.
干预措施: Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity (Device)
结局指标
主要结局
Hemorrhage Resorption Rate
时间窗: Hemorrhage resorption rate tracking starts from date of identified intraventricular hemorrhage on head ultrasound (usually within 1 week of life) and head ultrasounds weekly up to 4 months old
Measure rate at which neonate intraventricular hemorrhage is resorbed via serial head ultrasounds
Neurosurgical Interventions
时间窗: Number of neurosurgical interventions starts at birth and continues up to 4 months old
number of patients requiring neurosurgical intervention
Anterior Horn Width
时间窗: Ventricle volume tracking starts from date of identified intraventricular hemorrhage on head ultrasound (within 1 week of life) performed through weekly head ultrasounds up to 4 months old
Measure rate at which neonate intracranial pressure changes using anterior horn width (mm) derived from serial head ultrasounds.
Neurodevelopmental Outcomes at 6 months and 12 months of age
时间窗: Two time points at 6 months of age and 12 months of age
A phone survey will be conducted inquiring which developmental milestones have been met at 6 months (i.e., sitting independently, reaching to grab toys, knows familiar people, takes turns making sounds with care giver) and 12 months (plays interactive games, says mama/dada, looks for hidden objects, cruises, pincer grasp)
Ventricular Index
时间窗: Ventricle volume tracking starts from date of identified intraventricular hemorrhage on head ultrasound (within 1 week of life); and subsequent weekly head ultrasounds performed up to 4 months old
Measure rate at which neonate intracranial pressure changes using ventricular index (mm) derived from serial head ultrasounds.
Head Circumference
时间窗: Head Circumference tracking starts from birth and is performed daily up to 4 months old
Measure rate at which neonate intracranial pressure changes via head circumference (cm).
次要结局
未报告次要终点
研究者
Onajovwe Fofah, MD
Department of Pediatrics Chair
Rutgers, The State University of New Jersey