Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (NEONATAL ICH)
Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)
Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on ultrasound in extremely preterm infants. Papile classification is commonly used to grade the severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to be associated with adverse neurodevelopmental outcomes.
However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm infants has not been well described.
Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is not well established.
The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and follow their radiological, cognitive, motor and functional outcomes.
The study will focus on postnatal files, and on images performed as part of the child's follow-up during hospitalization and after discharge.
研究概览
地位
条件
详细说明
The study will be performed as a Retrospective chart review with key words : IVH, ICH of babies discharged from Laniado Hospital Neonatal care service or ICU, or being followed in the pediatric neurosurgical clinic and prematurity/neonatology clinic of the hospital.
All charts of such children will be included, to review clinical, and radiological available data.
Registration of Clinical, Radiological data as presented or submitted by the parents on Neurosurgical neonatology and Neurological Followups will be performed by PI or CI and coded in the data anonymously.
Follow up will be performed as clinically indicated without addition of any specific studies due to the research.
The endpoints of the study:
primary endpoint:
- How many children needed surgical intervention related to the hemorrhage (ICH, IVH) secondary endpoints:
- Clinical and functional outcome of children - REGARDING normal schooling, need for assistance in ADL in difference from the parallel normal child.
correlation between the type of hemorrhage, clinical data related to gestational age and weight at birth, and outcomes will be performed.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：LIANA ADANI BENI, MD
- 电话号码：97298609336
- 邮箱：DRLIANA.PEDNS@GMAIL.COM
研究联系人备份
- 姓名：INA FURMAN
- 电话号码：97298609127
- 邮箱：IFURMAN@LANIADO.ORG.IL
学习地点
-
-
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Netanya、以色列
- 招聘中
- Sharon Nechama, Laniado Hospital
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副研究员：
- Nechama Sharon, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage children who are followed by PI in the neurosurgical clinic in Laniado hospital and suffered from ICH or IVH and were treated elsewhere after birth -
Exclusion Criteria:
loss to followup within the first year after birth
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学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
enrolled babies with neonatal intracranial bleed
all babies who suffered from intra cranial or intraventricular bleed during neonatal period
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
need for surgery related to neonatal hemorrhage
大体时间：3 years
|
3 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
normal schooling according to age
大体时间：6 years
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6 years
|
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need for ADL assistance beyond acceptable per age
大体时间：6 years
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6 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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