Delayed Cord Clamping in VLBW Infants

Study Overview
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Brief Summary
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This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.

Detailed Description
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This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period. This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.

Official Title
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Delayed Cord Clamping in VLBW Infants Pilot Study

Conditions
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Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature

Intervention / Treatment
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* Procedure: Standard Cord Clamping
* Procedure: Delayed Cord Clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born at participating centers at 24-27 weeks gestation Singletons Obstetrician approval for enrollment Parental consent Exclusion Criteria: Prenatally diagnosed major congenital anomalies Intent to withhold or withdraw care Significant bleeding due to placenta previa or abruption

Ages Eligible for Study
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Maximum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Cord Clamping<br> | Procedure: Standard Cord Clamping<br>* Immediate clamping (<5 seconds) of the umbilical cord after delivery.<br>|
| Experimental: Delayed Cord Clamping<br> | Procedure: Delayed Cord Clamping<br>* Clamping of the umbilical cord at 30-45 seconds after birth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infants enrolled | Number of infants enrolled in the pilot within 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention to treat | Identify obstetricians willing to participate in randomizing subjects. | 6 months | 
| Hematocrit level |  | 4 hours of age | 
| Arterial blood pressure |  | 12 hours of age | 
| Use of volume expansion or pressor therapy |  | 24 hours of age | 
| Blood transfusions |  | Until hospital discharge or 120 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity