Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage

NCT03019692 | Recruiting

• 1 other identifier: 0148-16-LND-2016121
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonates Premature

Outcome Measures

Primary Outcomes (1)

• need for surgery related to neonatal hemorrhage

  3 years

Secondary Outcomes (2)

• normal schooling according to age

  6 years

• need for ADL assistance beyond acceptable per age

  6 years

Study Arms (1)

enrolled babies with neonatal intracranial bleed

all babies who suffered from intra cranial or intraventricular bleed during neonatal period

Eligibility Criteria

• Age: 1 Hour - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage within the first 3 months after birth or before discharge after delivery

You may qualify if:

• 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 -

You may not qualify if:

• loss to followup within the first year after birth

Sponsors & Collaborators

• Laniado Hospital: lead

Study Sites (1)

Sharon Nechama, Laniado Hospital

Netanya, Israel, Israel

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

LIANA ADANI BENI, MD

CONTACT

97298609336; DRLIANA.PEDNS@GMAIL.COM

INA FURMAN

CONTACT

97298609127; IFURMAN@LANIADO.ORG.IL

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Liana.Adani

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

IL (1)