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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Premature Infants

Treatments: Other: Telephone interview

Study type: Observational

Funder types: Other

Identifiers

NCT01912703

HYMC-297-13

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

700 participants in 2 patient groups

Preterm infants with IVH Grades I-II

Description:

Preterm infants (post-menstrual age 24-35 weeks) who were diagnosed with IVH Grades 1-2 in the neonatal intensive care unit (NICU).

Treatment:

Other: Telephone interview

Control Group

Description:

Preterm infants (post-menstrual age 24-35 weeks) who had no imaging evidence of IVH in the neonatal intensive care unit (NICU).

Treatment:

Other: Telephone interview