Sharon Nechama, Laniado Hospital
Netanya, Israel
Location status: Recruiting
NCT Number: NCT03019692
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.
Interested in participating?
Request Info1 hour–3 month
All sexes
Observational
Netanya, Israel
Location status: Recruiting
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:
correlation between the type of hemorrhage, clinical data related to gestational age and weight at birth, and outcomes will be performed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
-
Time frame: 3 years
Time frame: 6 years
Time frame: 6 years
Contact information is provided by the study sponsor or research team.
INA FURMAN
CONTACT
LIANA ADANI BENI, MD
CONTACT
Laniado Hospital
Other
Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)
Acronym: NEONATAL ICH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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