Effects of Milking the Umbilical Cord on Systemic Blood Flow

Study Overview
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Brief Summary
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Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.

Detailed Description
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The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions. This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.

Official Title
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A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants

Conditions
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Abnormal Vascular Flow

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants < 32 weeks gestation Exclusion Criteria: obstetrician's refusal to participate multiple gestations (if Di-Mo placentation) surrogate delivery parental desire for cord blood banking major congenital anomalies severe maternal illness placental abruption or previa ruptured uterus at delivery, or hemoperitoneum
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical Cord Milking<br>Umbilical Cord Milking involved milking the umbilical cord at birth. | Procedure: Umbilical Cord Milking<br>* UCM will be performed by the obstetric team by having the delivering obstetrician hold the infant below the mother's introitus at vaginal delivery or below the level of the incision at cesarean section and having the assistant (the second obstetrician) milk about 20 cm of umbilical cord over 2 seconds and repeating two additional times.<br>* Other names: stripping the umbilical cord;|
| Active Comparator: Immediate Cord Clamping<br>Umbilical cord is clamped soon after birth without any milking of the cord. | Procedure: Immediate Cord Clamping<br>* The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.<br>* Other names: routine clamping of the umbilical cord;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superior Vena Cava Flow | Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 6 hours. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 6 hours of life. | 6 hours of life | 
| Neurodevelopmental Outcomes | Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have improved neurodevelopmental outcomes. Neurodevelopmental follow-up data including cognitive, language, motor, social-emotional, and adaptive behavior composite scores from the Bayley Scales of Infant and Toddler Development (BSID-III) will be recorded when available. The presence of cerebral palsy, hearing and visual impairment will also be recorded when available. | between 18 and 36 months of life | 
| number of blood transfusions | Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have fewer blood transfusions at 36 weeks corrected gestational age. | 36 weeks corrected gestational age | 
| Superior Vena Cava Flow | Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 18 hours. | 18 hours of life | 
| Superior Vena Cava Flow | Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 30 hours. | 30 hours of life | 
| Blood Pressure | Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 18 hours of life. | at 18 hours of life | 
| Blood Pressure | Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 30 hours of life. | 30 hours of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superior vena cava flow, umbilical cord milking, hemodynamics, systemic blood flow