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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intraventricular Hemorrhage

Intervention / Treatment
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* Procedure: Umbilical Cord Milking
* Procedure: Delayed Cord Clamping


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Umbilical Cord Milking<br>Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds | Procedure: Umbilical Cord Milking<br>* 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.<br>|
| Active Comparator: Delayed Cord Clamping<br>Delayed clamping of the umbilical cord for 45-60 seconds | Procedure: Delayed Cord Clamping<br>* Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superior Vena Cava Flow |  | <12 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Room Interventions |  | 10 minutes of life | 
| Hemoglobin |  | <1 hour | 
| Hemoglobin |  | 12 hours | 
| Hemoglobin |  | 4 weeks of life | 
| Neurodevelopmental impairment 18-36 months |  | 18-36 months | 
| Severe intraventricular hemorrhage (grade 3 or 4) |  | up to 24 weeks after birth | 
| Phototherapy | Requirement and length of phototherapy | up to 24 weeks after birth | 
| Ionotropic support | Requirement and length of ionotropic support | up to 24 weeks after birth | 
| Neonatal intensive care unit (NICU) length of stay |  | up to 24 weeks after birth | 
| Necrotizing enterocolitis |  | up to 24 weeks after birth | 
| Number of blood transfusions while in the neonatal intensive care unit |  | up to 24 weeks after birth | 
| Ventilator time |  | up to 24 weeks after birth | 
| Apgar score <7 at 5 minutes |  | at 5 minutes after birth | 
| Umbilical cord pH < 7.0 |  | up to 30 minutes after birth | 
| Blood pressure in first 2 hours of admission to neonatal intensive care unit |  | 2 hours after birth | 
| Polycythemia |  | up to 24 hours of life | 
| Neonatal death |  | up to 24 weeks of life | 
| Use of uterotonic agents |  | up to 1 hour after birth | 
| Peak transcutaneous and/or serum bilirubin concentrations |  | up to 24 weeks after birt | 
| Maternal hemoglobin |  | within 48 hours after delivery | 
| Intraventricular Hemorrhage detected on Head Ultrasound |  | up to 24 weeks after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical cord milking, delayed cord clamping