Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 2:15 PM
Study NCT ID:
NCT03019692
Status:
RECRUITING
Last Update Posted:
2017-01-12
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage
Sponsor:
Laniado Hospital
Organization:
Study Overview
Official Title:
Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)
Status:
RECRUITING
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEONATAL ICH
Brief Summary:
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.
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.
Detailed Description:
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:
1. How many children needed surgical intervention related to the hemorrhage (ICH, IVH) secondary endpoints:
2. 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.
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:
1. How many children needed surgical intervention related to the hemorrhage (ICH, IVH) secondary endpoints:
2. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: