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

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ClinicalTrials.gov Identifier: NCT03019692
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Laniado Hospital

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.


Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)
Study Start Date : January 2017
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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



Primary Outcome Measures :
  1. need for surgery related to neonatal hemorrhage [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. normal schooling according to age [ Time Frame: 6 years ]
  2. need for ADL assistance beyond acceptable per age [ Time Frame: 6 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019692


Contacts
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Contact: LIANA ADANI BENI, MD 97298609336 DRLIANA.PEDNS@GMAIL.COM
Contact: INA FURMAN 97298609127 IFURMAN@LANIADO.ORG.IL

Locations
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Israel
Sharon Nechama, Laniado Hospital Recruiting
Netanya, Israel
Contact: Nechama Sharone, MD    972-544303356    nsharon@laniado.org.il   
Sub-Investigator: Nechama Sharon, MD         
Sponsors and Collaborators
Laniado Hospital

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Responsible Party: Laniado Hospital, Liana.Adani
ClinicalTrials.gov Identifier: NCT03019692     History of Changes
Other Study ID Numbers: 0148-16-LND-2016121
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Premature Birth
Hemorrhage
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases