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.

Study Overview

• Status: Recruiting
• Conditions: Neonates Premature

Detailed Description

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:

1. How many children needed surgical intervention related to the hemorrhage (ICH, IVH) secondary endpoints:
2. 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
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: LIANA ADANI BENI, MD; Phone Number: 97298609336; Email: DRLIANA.PEDNS@GMAIL.COM
• Study Contact Backup: Name: INA FURMAN; Phone Number: 97298609127; Email: IFURMAN@LANIADO.ORG.IL

Study Locations

• Israel
  • Netanya, Israel
    • Recruiting
    • Sharon Nechama, Laniado Hospital
    • Sub-Investigator: Nechama Sharon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

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

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
enrolled babies with neonatal intracranial bleed; all babies who suffered from intra cranial or intraventricular bleed during neonatal period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
need for surgery related to neonatal hemorrhage	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
normal schooling according to age	6 years
need for ADL assistance beyond acceptable per age	6 years

Collaborators and Investigators

• Sponsor: Laniado Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2027
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Hemorrhage; Premature Birth; Intracranial Hemorrhages
• Other Study ID Numbers: 0148-16-LND-2016121