Summary

Eligibility
for people ages 22 months to 42 months (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.

Official Title

Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Details

The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (CA). The corrected age may be extended out to 42 months CA due to Covid-19 pandemic for undetermined period of time.

Keywords

Neurodevelopmental Abnormality Neurodevelopmental impairment, prematurity Disability Umbilical cord milking Delayed cord clamping Premature Birth Congenital Abnormalities Randomized to Umbilical Cord Milking at birth Randomized to Delayed Cord Clamping at birth

Eligibility

You can join if…

Open to people ages 22 months to 42 months

  • Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.

You CAN'T join if...

  • Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.

Locations

  • University of California, Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • PIH Health Good Samaritan Hospital accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sharp HealthCare
ID
NCT03476980
Study Type
Interventional
Last Updated