Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (NEONATAL ICH)
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|ClinicalTrials.gov Identifier: NCT03019692|
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
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.
|Condition or disease|
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:
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2027|
|Estimated Study Completion Date :||January 2027|
enrolled babies with neonatal intracranial bleed
all babies who suffered from intra cranial or intraventricular bleed during neonatal period
- need for surgery related to neonatal hemorrhage [ Time Frame: 3 years ]
- normal schooling according to age [ Time Frame: 6 years ]
- need for ADL assistance beyond acceptable per age [ Time Frame: 6 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019692
|Contact: LIANA ADANI BENI, MD||97298609336||DRLIANA.PEDNS@GMAIL.COM|
|Contact: INA FURMAN||97298609127||IFURMAN@LANIADO.ORG.IL|
|Sharon Nechama, Laniado Hospital||Recruiting|
|Contact: Nechama Sharone, MD 972-544303356 email@example.com|
|Sub-Investigator: Nechama Sharon, MD|