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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01866982
Recruitment Status : Active, not recruiting
First Posted : June 3, 2013
Last Update Posted : April 25, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Intraventricular Hemorrhage Procedure: Umbilical Cord Milking Procedure: Delayed Cord Clamping

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Actual Study Start Date : July 2, 2013
Primary Completion Date : December 1, 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Superior Vena Cava Flow [ Time Frame: <12 hours of life ]

Secondary Outcome Measures :
  1. Delivery Room Interventions [ Time Frame: 10 minutes of life ]
  2. Hemoglobin [ Time Frame: <1 hour ]
  3. Hemoglobin [ Time Frame: 12 hours ]
  4. Hemoglobin [ Time Frame: 4 weeks of life ]
  5. Neurodevelopmental impairment 18-36 months [ Time Frame: 18-36 months ]
  6. Severe intraventricular hemorrhage (grade 3 or 4) [ Time Frame: up to 24 weeks after birth ]
  7. Phototherapy [ Time Frame: up to 24 weeks after birth ]
    Requirement and length of phototherapy

  8. Ionotropic support [ Time Frame: up to 24 weeks after birth ]
    Requirement and length of ionotropic support

  9. Neonatal intensive care unit (NICU) length of stay [ Time Frame: up to 24 weeks after birth ]
  10. Necrotizing enterocolitis [ Time Frame: up to 24 weeks after birth ]
  11. Number of blood transfusions while in the neonatal intensive care unit [ Time Frame: up to 24 weeks after birth ]
  12. Ventilator time [ Time Frame: up to 24 weeks after birth ]
  13. Apgar score <7 at 5 minutes [ Time Frame: at 5 minutes after birth ]
  14. Umbilical cord pH < 7.0 [ Time Frame: up to 30 minutes after birth ]
  15. Blood pressure in first 2 hours of admission to neonatal intensive care unit [ Time Frame: 2 hours after birth ]
  16. Polycythemia [ Time Frame: up to 24 hours of life ]
  17. Neonatal death [ Time Frame: up to 24 weeks of life ]
  18. Use of uterotonic agents [ Time Frame: up to 1 hour after birth ]
  19. Peak transcutaneous and/or serum bilirubin concentrations [ Time Frame: up to 24 weeks after birt ]
  20. Maternal hemoglobin [ Time Frame: within 48 hours after delivery ]
  21. Intraventricular Hemorrhage detected on Head Ultrasound [ Time Frame: up to 24 weeks after birth ]

Other Outcome Measures:
  1. Days on Oxygen [ Time Frame: during hospitalization ]
  2. Vaginal Delivered infants (no difference in interventions) [ Time Frame: up to 24 weeks after birth ]
  3. Cerebral Tissue Oxygenation [ Time Frame: Up to 24 hours of life ]
  4. Cardiac output by electric cardiometry [ Time Frame: up to 24 hours of life ]
  5. Stroke volume by electric cardiometry [ Time Frame: Up to 24 hours of life ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866982

United States, California
Loma Linda Medical Center
Loma Linda, California, United States, 92350
Sharp Mary Birch
San Diego, California, United States, 92123
University of California, San Diego
San Diego, California, United States, 92130
Sponsors and Collaborators
Sharp HealthCare
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Anup C Katheria, MD Sharp HealthCare
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anup Katheria, M.D., Director of Neonatal Research, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT01866982     History of Changes
Other Study ID Numbers: PREMOD
R03HD072934-01 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Anup Katheria, M.D., Sharp HealthCare:
umbilical cord milking
delayed cord clamping

Additional relevant MeSH terms:
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases