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

Intraventricular Hemorrhage Clinical Trial

— PREMOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866982
• Other study ID #: PREMOD
• Secondary ID: R03HD072934-01
• Status: Completed
• Phase: N/A
• Start date: July 2, 2013
• Est. completion date: January 10, 2018

Study information

• Verified date: May 2018
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: January 10, 2018
• Est. primary completion date: December 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12. — View Citation

Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Days on Oxygen		during hospitalization
Other	Vaginal Delivered infants (no difference in interventions)		up to 24 weeks after birth
Other	Cerebral Tissue Oxygenation		Up to 24 hours of life
Other	Cardiac output by electric cardiometry		up to 24 hours of life
Other	Stroke volume by electric cardiometry		Up to 24 hours of life
Primary	Superior Vena Cava Flow		<12 hours of life
Secondary	Delivery Room Interventions		10 minutes of life
Secondary	Hemoglobin		<1 hour
Secondary	Hemoglobin		12 hours
Secondary	Hemoglobin		4 weeks of life
Secondary	Neurodevelopmental impairment 18-36 months		18-36 months
Secondary	Severe intraventricular hemorrhage (grade 3 or 4)		up to 24 weeks after birth
Secondary	Phototherapy	Requirement and length of phototherapy	up to 24 weeks after birth
Secondary	Ionotropic support	Requirement and length of ionotropic support	up to 24 weeks after birth
Secondary	Neonatal intensive care unit (NICU) length of stay		up to 24 weeks after birth
Secondary	Necrotizing enterocolitis		up to 24 weeks after birth
Secondary	Number of blood transfusions while in the neonatal intensive care unit		up to 24 weeks after birth
Secondary	Ventilator time		up to 24 weeks after birth
Secondary	Apgar score <7 at 5 minutes		at 5 minutes after birth
Secondary	Umbilical cord pH < 7.0		up to 30 minutes after birth
Secondary	Blood pressure in first 2 hours of admission to neonatal intensive care unit		2 hours after birth
Secondary	Polycythemia		up to 24 hours of life
Secondary	Neonatal death		up to 24 weeks of life
Secondary	Use of uterotonic agents		up to 1 hour after birth
Secondary	Peak transcutaneous and/or serum bilirubin concentrations		up to 24 weeks after birt
Secondary	Maternal hemoglobin		within 48 hours after delivery
Secondary	Intraventricular Hemorrhage detected on Head Ultrasound		up to 24 weeks after birth