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

Not Applicable

Completed

• Conditions: Intraventricular Hemorrhage
• Interventions: Procedure: Delayed Cord Clamping; Procedure: Umbilical Cord Milking

• Registration Number: NCT01866982
• Lead Sponsor: Sharp HealthCare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-03
• Study Start: 2013-07-02
• Primary Completion: 2014-12-01
• Study Completion: 2018-01-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Cord Clamping	Delayed Cord Clamping	Delayed clamping of the umbilical cord for 45-60 seconds
Umbilical Cord Milking	Umbilical Cord Milking	Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds

Primary Outcome Measures

Name	Time	Method
Superior Vena Cava Flow	<12 hours of life

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Loma Linda Medical Center; 🇺🇸 Loma Linda, California, United States

Sharp Mary Birch; 🇺🇸 San Diego, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States