Clinical trial NCT01866982: The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Official title: The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraventricular Hemorrhage
Keywords: umbilical cord milking
delayed cord clamping
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-06-03
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Superior Vena Cava Flow
timeFrame: <12 hours of life
Secondary outcomes:
measure: Delivery Room Interventions
timeFrame: 10 minutes of life
measure: Hemoglobin
timeFrame: <1 hour
measure: Hemoglobin
timeFrame: 12 hours
measure: Hemoglobin
timeFrame: 4 weeks of life
measure: Neurodevelopmental impairment 18-36 months
timeFrame: 18-36 months
measure: Severe intraventricular hemorrhage (grade 3 or 4)
timeFrame: up to 24 weeks after birth
measure: Phototherapy
timeFrame: up to 24 weeks after birth
measure: Ionotropic support
timeFrame: up to 24 weeks after birth
measure: Neonatal intensive care unit (NICU) length of stay
timeFrame: up to 24 weeks after birth
measure: Necrotizing enterocolitis
timeFrame: up to 24 weeks after birth
measure: Number of blood transfusions while in the neonatal intensive care unit
timeFrame: up to 24 weeks after birth
measure: Ventilator time
timeFrame: up to 24 weeks after birth
measure: Apgar score <7 at 5 minutes
timeFrame: at 5 minutes after birth
measure: Umbilical cord pH < 7.0
timeFrame: up to 30 minutes after birth
measure: Blood pressure in first 2 hours of admission to neonatal intensive care unit
timeFrame: 2 hours after birth
measure: Polycythemia
timeFrame: up to 24 hours of life
measure: Neonatal death
timeFrame: up to 24 weeks of life
measure: Use of uterotonic agents
timeFrame: up to 1 hour after birth
measure: Peak transcutaneous and/or serum bilirubin concentrations
timeFrame: up to 24 weeks after birt
measure: Maternal hemoglobin
timeFrame: within 48 hours after delivery
measure: Intraventricular Hemorrhage detected on Head Ultrasound
timeFrame: up to 24 weeks after birth
Other outcomes:
measure: Days on Oxygen
timeFrame: during hospitalization
measure: Vaginal Delivered infants (no difference in interventions)
timeFrame: up to 24 weeks after birth
measure: Cerebral Tissue Oxygenation
timeFrame: Up to 24 hours of life
measure: Cardiac output by electric cardiometry
timeFrame: up to 24 hours of life
measure: Stroke volume by electric cardiometry
timeFrame: Up to 24 hours of life
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: Sharp HealthCare
name: Anup C Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.