NCT03019692|Recruiting
Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage
NEONATAL ICH
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NEONATAL ICH
Sponsor study identifier
observational
50
1 country
1
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
January 11, 2017
Actual (reported)January 12, 2017
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
need for surgery related to neonatal hemorrhage
3 years
normal schooling according to age
6 years
need for ADL assistance beyond acceptable per age
6 years
all babies who suffered from intra cranial or intraventricular bleed during neonatal period
newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage within the first 3 months after birth or before discharge after delivery
Sharon Nechama, Laniado Hospital
Netanya, Israel, Israel
First Submitted
January 11, 2017
First Posted
January 12, 2017
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2027
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 12, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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