Overview

This trial is active, not recruiting.

Condition intraventricular hemorrhage
Treatments umbilical cord milking, delayed cord clamping
Sponsor Sharp HealthCare
Collaborator National Institutes of Health (NIH)
Start date August 2013
End date December 2014
Trial size 200 participants
Trial identifier NCT01866982, PREMOD, R03HD072934-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Active Comparator)
Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds
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 clamping of the umbilical cord for 45-60 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.

Primary Outcomes

Measure
Superior Vena Cava Flow
time frame: <12 hours of life

Secondary Outcomes

Measure
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
Ionotropic support
time frame: up to 24 weeks after birth
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Principal investigator Anup C Katheria, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Sharp HealthCare.