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Completed

NCT Number: NCT01866982

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

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.

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Key information

Conditions

Intraventricular Hemorrhage

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda Medical Center, Loma Linda, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Milking

Procedure

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.

Delayed Cord Clamping

Procedure

Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.

Primary outcomes

  1. Superior Vena Cava Flow

    Time frame: <12 hours of life

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

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

Registry information

Acronym: PREMOD

Important dates

Study start
2013
Primary completion
2014
Study completion
2018
First posted
Jun 3, 2013
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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