Umbilical Cord Milking in Non-Vigorous Infants

NCT03631940 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1730

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Birth Asphyxia

Interventions

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.

Sponsors & Collaborators

  • Sharp Mary Birch Hospital for Women & Newborns

    collaborator OTHER
  • Sharp Grossmont Hospital

    collaborator OTHER
  • University of Utah

    collaborator OTHER
  • University of Alberta

    collaborator OTHER
  • Poznan University of Medical Sciences

    collaborator OTHER
  • IWK Health Centre

    collaborator OTHER
  • University of California, Davis

    collaborator OTHER
  • Loma Linda University

    collaborator OTHER
  • George Washington University

    collaborator OTHER
  • Providence Hospital

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • Anup Katheria, MD · Sharp HealthCare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
35 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-05
Primary Completion
2021-06-01
Completion
2023-09-26

Countries

  • United States
  • Canada
  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631940 on ClinicalTrials.gov