Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Summary

This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC.

\* The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.

Conditions

• Intraventricular Haemorrhage Neonatal
• Death; Neonatal

Interventions

PROCEDURE

Umbilical cord milking UCM

At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. This procedure infuses a placental transfusion of blood into the preterm neonate and can be done in 15-20 seconds.

PROCEDURE

Delayed cord clamping DCC

At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.

Sponsors & Collaborators

• Sharp Mary Birch Hospital for Women & Newborns

  collaborator OTHER

• Loma Linda University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Providence Hospital

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University College Cork

  collaborator OTHER

• University of Ulm

  collaborator OTHER

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

  collaborator NIH

• Christiana Care Health Services

  collaborator OTHER

• Sharp Grossmont Hospital

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• PIH Health Good Samaritan Hospital

  collaborator UNKNOWN

• University of California, Irvine

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Cook County Health

  collaborator OTHER_GOV

• St. Louis University

  collaborator OTHER

• LAC+USC Medical Center

  collaborator OTHER

• Sharp HealthCare

  lead OTHER

Principal Investigators

• Anup C Katheria, MD · Sharp HealthCare

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

33 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-06

Primary Completion

2022-09-16

Completion

2022-09-16

Countries

• United States
• Canada
• Germany
• Ireland

Study Locations