Delayed Cord Clamping in Very Low Birth Weight Infants

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.

Detailed Description
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Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood. Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping. Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.

Official Title
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Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial

Conditions
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Premature Infants, Very Low Birth Weight Infants, Intraventricular Hemorrhage

Intervention / Treatment
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* Procedure: Delayed cord clamping at 30 seconds
* Procedure: Delayed cord clamping at 60 seconds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who are expected to deliver a very low birth weight infant Neonates born weighing >= 500g and <1500 grams Mother 18 years of age or older English speaking mother Exclusion Criteria: Placental abruption Vasa previa Fetal hydrops or other signs of fetal volume overload Other major fetal anomalies Placenta Accreta Mother < 18 years of age Non-English speaking mother Infants >= 1500g (3.3 lbs) or <500g

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30 seconds<br>For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery. | Procedure: Delayed cord clamping at 30 seconds<br>* For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery<br>|
| Experimental: 60 seconds<br>For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery. | Procedure: Delayed cord clamping at 60 seconds<br>* For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraventricular hemorrhage | Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage. | During NICU admission up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin and hematocrit | Neonates will be followed for up to 6-months and initial H/H will be recorded. | During NICU admission up to 6 months | 
| Need for blood transfusion | Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion. | During NICU admission up to 6 months | 
| Bilirubin levels | Neonates will be followed for up to 6-months and assessed for clinical jaundice. | During NICU admission up to 6 months | 
| Delivery room temperature | Neonates will be assessed for hypothermia at the time of delivery. | Delivery | 

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