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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare
ClinicalTrials.gov Identifier:
NCT01866982
First received: May 29, 2013
Last updated: November 10, 2015
Last verified: November 2015
  Purpose
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 Intervention
Intraventricular Hemorrhage
Procedure: Umbilical Cord Milking
Procedure: Delayed Cord Clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants

Resource links provided by NLM:


Further study details as provided by Sharp HealthCare:

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

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

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

  • Neonatal intensive care unit (NICU) length of stay [ Time Frame: up to 24 weeks after birth ]
  • Necrotizing enterocolitis [ Time Frame: 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 ]
  • Ventilator time [ Time Frame: up to 24 weeks after birth ]
  • Apgar score <7 at 5 minutes [ Time Frame: at 5 minutes after birth ]
  • Umbilical cord pH < 7.0 [ Time Frame: 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 ]
  • Polycythemia [ Time Frame: up to 24 hours of life ]
  • Neonatal death [ Time Frame: up to 24 weeks of life ]
  • Use of uterotonic agents [ Time Frame: up to 1 hour after birth ]
  • Peak transcutaneous and/or serum bilirubin concentrations [ Time Frame: up to 24 weeks after birt ]
  • Maternal hemoglobin [ Time Frame: within 48 hours after delivery ]
  • Intraventricular Hemorrhage detected on Head Ultrasound [ Time Frame: up to 24 weeks after birth ]

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

Estimated Enrollment: 200
Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866982

Locations
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
National Institutes of Health (NIH)
Investigators
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 
Study First Received: May 29, 2013
Last Updated: November 10, 2015

Keywords provided by Sharp HealthCare:
umbilical cord milking
delayed cord clamping

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

ClinicalTrials.gov processed this record on February 23, 2017