NCT03476980

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 22 Months – 42 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Neurodevelopmental Abnormality

Interventions

Type	Name	Description
PROCEDURE	Randomized to Umbilical Cord Milking at birth	The subjects in this group were randomized to UCM X4 at birth. This procedure infuses a placental transfusion of blood by milking the umbilical cord towards the infant at birth.
PROCEDURE	Randomized to Delayed Cord Clamping at birth	The subjects in this group were randomized to DCC at birth. At delivery, the obstetrician was instructed to delay clamping of the umbilical cord for 60 seconds.

Timeline

• Start date: 2019-07-06
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2018-03-26
• Last updated: 2022-11-25

Locations

18 sites across 4 countries: United States, Canada, Germany, Ireland