Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping) (PREMOD2FU)

  • End date
    Jun 23, 2024
  • participants needed
  • sponsor
    Sharp HealthCare
Updated on 23 April 2022


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.


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.

Condition Neurodevelopmental Abnormality
Treatment Randomized to Umbilical Cord Milking at birth, Randomized to Delayed Cord Clamping at birth
Clinical Study IdentifierNCT03476980
SponsorSharp HealthCare
Last Modified on23 April 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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