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

Neonates Premature Clinical Trial

— NEONATAL ICH  

Official title:

Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03019692
• Other study ID #: 0148-16-LND-2016121
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2017
• Last updated: January 11, 2017
• Start date: January 2017
• Est. completion date: January 2027

Study information

• Verified date: January 2017
• Source: Laniado Hospital
• Contact: LIANA ADANI BENI, MD
• Phone: 97298609336
• Email: DRLIANA.PEDNS[@]GMAIL.COM
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages
• Neonates Premature
• Premature Birth

Locations

Country	Name	City	State
Israel	Sharon Nechama, Laniado Hospital	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Laniado Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	need for surgery related to neonatal hemorrhage		3 years	No
Secondary	normal schooling according to age		6 years	No
Secondary	need for ADL assistance beyond acceptable per age		6 years	No