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

Premature Infants Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01912703
• Other study ID #: HYMC-297-13
• 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

• Premature Infants

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