Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (NEONATAL ICH)
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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:
- 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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: LIANA ADANI BENI, MD
- Numéro de téléphone: 97298609336
- E-mail: DRLIANA.PEDNS@GMAIL.COM
Sauvegarde des contacts de l'étude
- Nom: INA FURMAN
- Numéro de téléphone: 97298609127
- E-mail: IFURMAN@LANIADO.ORG.IL
Lieux d'étude
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Netanya, Israël
- Recrutement
- Sharon Nechama, Laniado Hospital
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Sous-enquêteur:
- Nechama Sharon, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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enrolled babies with neonatal intracranial bleed
all babies who suffered from intra cranial or intraventricular bleed during neonatal period
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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need for surgery related to neonatal hemorrhage
Délai: 3 years
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3 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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normal schooling according to age
Délai: 6 years
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6 years
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need for ADL assistance beyond acceptable per age
Délai: 6 years
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6 years
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies cardiovasculaires
- Maladies vasculaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Complications de grossesse
- Complications du travail obstétrical
- Travail obstétrique, prématuré
- Hémorragie
- Naissance prématurée
- Hémorragies intracrâniennes
Autres numéros d'identification d'étude
- 0148-16-LND-2016121
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