Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- MRI brain injury score
研究概览
简要总结
The purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (OCT) imaging technique in newborn infants with HIE that improves our ability to assess the range of retinal effects from HIE and to diagnose and monitor treatments of HIE.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 20 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants are eligible if:
- •Admitted to the intensive care nursery, outborn or inborn, with a clinical diagnosis of HIE; and with the approval of the neonatologist
- •A parent or legal guardian provides written informed consent
排除标准
- •Potentially eligible infants will be excluded if:
- •Congenital or chromosomal anomaly that has a profound impact on brain or eye development (e.g. anencephaly, congenital cataract or Peter's anomaly) and infants for whom there has been a clinical decision to limit life support.
结局指标
主要结局
MRI brain injury score
时间窗: from 4 to 14 days after birth
MRI scoring: global score of overall injury \[0-138\] characterized as mild \[0-11\], moderate \[12-32\], or severe \[\>32\].
Retinal injury morphologies on optical coherence tomography
时间窗: birth to 10 days
Composite injury score from presence or absence of 5 morphologies on optical coherence tomography: 1) cystoid spaces,2) ganglion cell layer abnormality, 3) paracentral acute middle maculopathy, 4) hemorrhages, 5) photoreceptor ellipsoid zone at the fovea
Inner macular layer thickness on optical coherence tomography
时间窗: birth to 10 days
Deviation in the thickness from internal limiting membrane to outer plexiform layer across the macula (500, 1000 and 2000μm from the fovea): 0 to 500 microns
Retinal nerve fiber layer thickness on optical coherence tomography
时间窗: birth to 10 days
Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns
Clinical hypoxic ischemic encephalopathy score
时间窗: birth to 6 hours
hypoxic ischemic encephalopathy clinical score, within the first 6 hours of life, based on the modified Sarnat staging scale: mild, moderate or severe
次要结局
- Choroidal thickness on optical coherence tomography(birth to 9 weeks)
- thickness of macular nerve fiber layer(birth to 9 weeks)
- thickness of macular ganglion cell layer(birth to 9 weeks)
- thickness of inner nuclear layer(birth to 9 weeks)
- Longitudinal change in retinal nerve fiber layer thickness on optical coherence tomography(birth to 9 weeks)
- Total macular layer thickness on optical coherence tomography(birth to 9 weeks)
- pattern of MRI injury(from 4 to 14 days after birth)
- Optic nerve head morphology(birth to 9 weeks)
- Center foveal thickness(birth to 9 weeks)
- thickness of photoreceptor layer(birth to 9 weeks)
- Longitudinal change in inner macular layer thickness on optical coherence tomography(birth to 9 weeks)
- Center ellipsoid zone thickness(birth to 9 weeks)
- thickness of inner plexiform layer(birth to 9 weeks)
- Longitudinal change in retinal injury morphologies on optical coherence tomography(birth to 9 weeks)
- Late clinical hypoxic ischemic encephalopathy score(1 to 8 days)