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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Superior Vena Cava Flow
Time Frame: <12 hours of life
<12 hours of life

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sharp HealthCare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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