Neonates Premature Clinical Trial
Official title:
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.
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.
;
Observational Model: Cohort, Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03855202 -
The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
|
Phase 1 |