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

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.

Study Overview

• Status: Unknown
• Conditions: Premature Infants
• Intervention / Treatment: Other: Telephone interview

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Roei Abramovitch, MD; Phone Number: 972-50-3205548; Email: roeiabra@gmail.com

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants born in 2007-2011 at the Hillel Yaffe Medical Center

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm infants with IVH Grades I-II; Preterm infants (post-menstrual age 24-35 weeks) who were diagnosed with IVH Grades 1-2 in the neonatal intensive care unit (NICU).	Other: Telephone interview; Subjects with incomplete data will be asked to complete a telephone interview
Control Group; Preterm infants (post-menstrual age 24-35 weeks) who had no imaging evidence of IVH in the neonatal intensive care unit (NICU).	Other: Telephone interview; Subjects with incomplete data will be asked to complete a telephone interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: July 29, 2013
• First Submitted That Met QC Criteria: July 30, 2013
• First Posted (Estimate): July 31, 2013

Study Record Updates

• Last Update Posted (Estimate): July 31, 2013
• Last Update Submitted That Met QC Criteria: July 30, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: HYMC-297-13