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

• Conditions: Premature Infants
• Interventions: Other: Telephone interview

• Registration Number: NCT01912703
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-30
• Last Update Submitted: 2013-07-30
• Study First Posted: 2013-07-31
• Last Update Posted: 2013-07-31
• Study Start: 2013-12
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infants with IVH Grades I-II	Telephone interview	Preterm infants (post-menstrual age 24-35 weeks) who were diagnosed with IVH Grades 1-2 in the neonatal intensive care unit (NICU).
Control Group	Telephone interview	Preterm infants (post-menstrual age 24-35 weeks) who had no imaging evidence of IVH in the neonatal intensive care unit (NICU).

Primary Outcome Measures

Name	Time	Method
General Neurodevelopmental Assessment	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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel