Recruiting

Milking & Delayed Cord Clamping

Sponsor:

Sharp HealthCare

Code:

NCT03476980

Conditions

Neurodevelopmental Abnormality

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Not accepted

Interventions

Randomized to Umbilical Cord Milking at birth

Randomized to Delayed Cord Clamping at birth

Study Details

Brief 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

Study ID

NCT03476980

Start date

Jul 6, 2019

Status verified date

Nov, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.

Exclusion Criteria:

  • Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Randomized to Umbilical Cord Milking at birth

Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.

active comparator: Randomized to Delayed Cord Clamping at birth

Delayed clamping of the umbilical cord at birth.

Interventions

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.

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.

Primary outcome measure

  • Developmental Outcome [ Time Frame: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic. ]

Central Contacts and Locations

Central contacts

Anup Katheria, MD

858 939-4170anup.katheria@sharp.com

Jane Steen, RN

858 939-4114

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35294-0004

Contacts

Wally Carlo, MD

wcarlo@peds.uab.edu

Loma Linda Medical Center

Recruiting

Loma Linda, California, United States, 92350

Contacts

Farha Vora, MD

FVora@llu.edu

LAC+USC Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Fiona Wertheimer, DO

323-409-3322

PIH Health Good Samaritan Hospital

Recruiting

Los Angeles, California, United States, 90033

Contacts

Manoj Biniwale, MD

323-409-3406Biniwale@usc.edu

University of California, Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Fayez Bany-Mohammed, MD

714-456-6933fbanymoh@hs.uci.edu

Sharp Grossmont Hospital

Recruiting

San Diego, California, United States, 91942

Contacts

Kevin Fulford, MD

kevin.fulford@sharp.com

Sharp Mary Birch Hospital for Women and Newborns

Recruiting

San Diego, California, United States, 92123

Contacts

Yvonne Vaucher, MD

yvaucher@ucsd.edu

Anup Katheria, MD

anup.katheria@sharp.com

Principal Investigator:

Anup Katheria, MD

Christiana Care

Recruiting

Newark, Delaware, United States, 19718

Contacts

Shazia Bhat, MD

SBhat@ChristianaCare.org

John H. Stroger, Jr. Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Janardhan Mydam, MD

jmydam@cookcountyhhs.org

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Simon Karam, MD

skaram@umc.edu

Rachael Morris, MD

rmorris@umc.edu

St. Louis University

Recruiting

Saint Louis, Missouri, United States, 63104

Contacts

Nitin Chouthai, MD

nitin.chouthai@health.slu.edu

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Vivek Narendran, MD

vivek.narendran@cchmc.org

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225-6603

Contacts

Michele Raddish, MD

Michele.Raddish@providence.org

Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Sue Beers, PhD

beerssr@upmc.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Erin Clark, MD

erin.clark@hsc.utah.edu

Tara DuPont, MD

tara.dupont@hsc.utah.edu

Governors of University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2R3

Contacts

Matthew Hicks, MD

matt.hicks@ahs.ca

More Information

Sponsor

Sharp HealthCare

Last update posted

Nov 25, 2022

Last verified

Nov, 2022

Keywords

  • Neurodevelopmental impairment, prematurity
  • Disability
  • Umbilical cord milking
  • Delayed cord clamping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sharp HealthCare on 2022-11-25.