The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants (PREMOD)

May 22, 2018 updated by: Anup Katheria, M.D., Sharp HealthCare
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. However, some studies suggest that delayed cord clamping may not increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical cord may give more blood in babies delivered by Cesarean Section may improve perfusion and reduce bleeding in the brain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda Medical Center
      • San Diego, California, United States, 92123
        • Sharp Mary Birch
      • San Diego, California, United States, 92130
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 23 0/7 - 31 6/7 weeks gestation

Exclusion Criteria:

  • Planned vaginal breech delivery
  • Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
  • Fetal death in utero
  • Red cell isoimmunization
  • Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
  • Placenta accreta or abruption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Umbilical Cord Milking
Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds
Procedure: Umbilical Cord Milking
Umbilical cord milked toward the neonate four times at a speed of 20cm/2seconds, prior to clamping and cutting umbilical cord. Procedure takes about 10-20 seconds.
Active Comparator: Delayed Cord Clamping
Delayed clamping of the umbilical cord for 45-60 seconds
Procedure: Delayed Cord Clamping
Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Superior Vena Cava Flow
Time Frame: <12 hours of life
<12 hours of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery Room Interventions
Time Frame: 10 minutes of life
10 minutes of life
Hemoglobin
Time Frame: <1 hour
<1 hour
Hemoglobin
Time Frame: 12 hours
12 hours
Hemoglobin
Time Frame: 4 weeks of life
4 weeks of life
Neurodevelopmental impairment 18-36 months
Time Frame: 18-36 months
18-36 months
Severe intraventricular hemorrhage (grade 3 or 4)
Time Frame: up to 24 weeks after birth
up to 24 weeks after birth
Phototherapy
Time Frame: up to 24 weeks after birth
Requirement and length of phototherapy
up to 24 weeks after birth
Ionotropic support
Time Frame: up to 24 weeks after birth
Requirement and length of ionotropic support
up to 24 weeks after birth
Neonatal intensive care unit (NICU) length of stay
Time Frame: up to 24 weeks after birth
up to 24 weeks after birth
Necrotizing enterocolitis
Time Frame: up to 24 weeks after birth
up to 24 weeks after birth
Number of blood transfusions while in the neonatal intensive care unit
Time Frame: up to 24 weeks after birth
up to 24 weeks after birth
Ventilator time
Time Frame: up to 24 weeks after birth
up to 24 weeks after birth
Apgar score <7 at 5 minutes
Time Frame: at 5 minutes after birth
at 5 minutes after birth
Umbilical cord pH < 7.0
Time Frame: up to 30 minutes after birth
up to 30 minutes after birth
Blood pressure in first 2 hours of admission to neonatal intensive care unit
Time Frame: 2 hours after birth
2 hours after birth
Polycythemia
Time Frame: up to 24 hours of life
up to 24 hours of life
Neonatal death
Time Frame: up to 24 weeks of life
up to 24 weeks of life
Use of uterotonic agents
Time Frame: up to 1 hour after birth
up to 1 hour after birth
Peak transcutaneous and/or serum bilirubin concentrations
Time Frame: up to 24 weeks after birt
up to 24 weeks after birt
Maternal hemoglobin
Time Frame: within 48 hours after delivery
within 48 hours after delivery
Intraventricular Hemorrhage detected on Head Ultrasound
Time Frame: up to 24 weeks after birth
up to 24 weeks after birth

Other Outcome Measures

Outcome Measure
Time Frame
Days on Oxygen
Time Frame: during hospitalization
during hospitalization
Vaginal Delivered infants (no difference in interventions)
Time Frame: up to 24 weeks after birth
up to 24 weeks after birth
Cerebral Tissue Oxygenation
Time Frame: Up to 24 hours of life
Up to 24 hours of life
Cardiac output by electric cardiometry
Time Frame: up to 24 hours of life
up to 24 hours of life
Stroke volume by electric cardiometry
Time Frame: Up to 24 hours of life
Up to 24 hours of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharp HealthCare

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 10, 2018

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (Estimate)

June 3, 2013

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREMOD
  • R03HD072934-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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