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

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.

Conditions

• Neurodevelopmental Abnormality

Interventions

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.

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

• Christiana Care Health Services

  collaborator OTHER

• Thrasher Research Fund

  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 Katheria, MD · Sharp Mary Birch Hospital for Women & Newborns

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

22 Months

Max Age

42 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-06

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• United States
• Canada
• Germany
• Ireland

Study Locations