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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01912703
Other study ID # HYMC-297-13
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 29, 2013
Last updated July 30, 2013
Start date December 2013
Est. completion date December 2014

Study information

Verified date July 2013
Source Hillel Yaffe Medical Center
Contact Roei Abramovitch, MD
Phone 972-50-3205548
Email roeiabra@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 700
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 7 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Telephone interview
Subjects with incomplete data will be asked to complete a telephone interview

Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary General Neurodevelopmental Assessment 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. Seven years No
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