NCT03682042

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up

A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,442 (estimated)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 22 Months – 26 Months
• Healthy volunteers: Not accepted

Summary

An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).

Detailed description

The CORDMILK Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were non-vigorous at birth and enrolled in the CORDMILK trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ECC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Birth Asphyxia

Interventions

Type	Name	Description
OTHER	Umbilical Cord Milking	At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.

Timeline

• Start date: 2022-10-17
• Primary completion: 2027-08-30
• Completion: 2027-10-30
• First posted: 2018-09-24
• Last updated: 2025-07-10

Locations

9 sites across 1 country: India