Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks

Study Overview
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Brief Summary
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Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.

Official Title
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Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial

Conditions
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Prematurity

Intervention / Treatment
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* Procedure: Milking group
* Procedure: Immediate cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm neonates delivered between 24 0/7 and 32 6/7 Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age Written parental consent Exclusion Criteria: Multiple gestation pregnancies (twins or higher order multiples) Rh or other antibody sensitization Hydrops fetalis Known major congenital abnormality Suspected abruptio placentae

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate umbilical cord clamping<br>The umbilical cord will be clamped immediately after delivery. | Procedure: Immediate cord clamping<br>* The umbilical cord will be clamped and cut immediately after delivery of the neonate.<br>|
| Experimental: Cord milking group<br>The umbilical cord will be milked in direction towards neonate 4 times over the course of 10 minutes. | Procedure: Milking group<br>* The umbilical cord will be milked toward the neonate four times prior to clamping the umbilical cord.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin during NICU course |  | within 24 hours of birth and through NICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-min Apgar |  | at 1 minute of life | 
| 5 min Apgar |  | at 5 minutes of life | 
| Blood Sugar upon admission to NICU |  | within 1 hour of birth | 
| Temperature on admission to NICU |  | within 1 hour of birth | 
| Cord blood pH |  | within 1 hour of birth | 
| Blood pressure upon admission to NICU |  | within 1 hour of birth | 
| Number of volume challenges in first 24 hours of life |  | at 24 hours of birth | 
| Days requiring ventilation |  | 2 months | 
| Neonatal death |  | 6 months | 
| Length of hospital stay |  | 6 months | 
| Intraventricular hemorrhage |  | 6 months | 
| Number and volume of blood transfusions |  | 10 units | 
| duration of phototherapy |  | 1 month | 
| Maximum serum bilirubin |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonate, umbilical cord, cord milking, prematurity