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Clinical Trials/NCT01912703
NCT01912703
Unknown
N/A

The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years

Hillel Yaffe Medical Center1 site in 1 country700 target enrollmentDecember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Infants
Sponsor
Hillel Yaffe Medical Center
Enrollment
700
Locations
1
Primary Endpoint
General Neurodevelopmental Assessment
Last Updated
12 years ago

Overview

Brief Summary

It is well-known that preterm delivery can be accompanied by complications. One of these complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes, including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim of this study is to determine whether they do have any neurodevelopmental outcomes.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2014
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All preterm infants born at 35 weeks or less
  • Underwent at least 1 brain ultrasound
  • Diagnosed with IVH Grades 1-2
  • Had no other severe illness in NICU
  • Had neurodevelopmental follow-up

Exclusion Criteria

  • All others

Outcomes

Primary Outcomes

General Neurodevelopmental Assessment

Time Frame: Seven years

Retrospective study of preterm infants born in the years 2007-2011 and suffered IVH Grades 1-2 who have undergone a general neurodevelopmental assessment in the Institute for Child Development in Hillel Yaffe Medical Center at ages 1-7. This assessment will indicate whether IVH Grades 1-2 has any neurodevelopmental effect on these children.

Study Sites (1)

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