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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03019692
Date of registration: 11/01/2017
Prospective Registration: No
Primary sponsor: Laniado Hospital
Public title: Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage NEONATAL ICH
Scientific title: Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)
Date of first enrolment: January 2017
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03019692
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Israel
Contacts
Name:     Nechama Sharone, MD
Address: 
Telephone: 972-544303356
Email: nsharon@laniado.org.il
Affiliation: 
Name:     LIANA ADANI BENI, MD
Address: 
Telephone: 97298609336
Email: DRLIANA.PEDNS@GMAIL.COM
Affiliation: 
Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 3 Months
Gender: All
Health Condition(s) or Problem(s) studied
Neonates Premature
Intervention(s)
Primary Outcome(s)
need for surgery related to neonatal hemorrhage [Time Frame: 3 years]
Secondary Outcome(s)
need for ADL assistance beyond acceptable per age [Time Frame: 6 years]
normal schooling according to age [Time Frame: 6 years]
Secondary ID(s)
0148-16-LND-2016121
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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