NCT03631940

Umbilical Cord Milking in Non-Vigorous Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,730 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 35 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

Summary

The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.

Detailed description

At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems. The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.

Conditions

• Birth Asphyxia

Interventions

Type	Name	Description
PROCEDURE	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 15-20 seconds.
PROCEDURE	Early Cord Clamping	The umbilical cord is clamped within 60 seconds of delivery.

Timeline

• Start date: 2019-01-05
• Primary completion: 2021-06-01
• Completion: 2023-09-26
• First posted: 2018-08-15
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

10 sites across 3 countries: United States, Canada, Poland