Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03019692

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

1 hour–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Sharon Nechama, Laniado Hospital

Netanya, Israel

Location status: Recruiting

Location contact

Nechama Sharon, MD

SUB_INVESTIGATOR

Nechama Sharone, MD

CONTACT

[email protected]

972-544303356

About this study

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.

Who can participate

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

-

Treatment and study plan

Primary outcomes

  1. need for surgery related to neonatal hemorrhage

    Time frame: 3 years

Secondary outcomes

  1. normal schooling according to age

    Time frame: 6 years

  2. need for ADL assistance beyond acceptable per age

    Time frame: 6 years

Study contacts

Contact information is provided by the study sponsor or research team.

INA FURMAN

CONTACT

[email protected]

97298609127

LIANA ADANI BENI, MD

CONTACT

[email protected]

97298609336

Sponsors and collaborators

Lead sponsor

Laniado Hospital

Other

Registry information

Official study title

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

Acronym: NEONATAL ICH

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2017
Registry last updated
Jan 12, 2017

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.

Published trials that share one or more normalized conditions with this study.