Delayed Cord Clamping in Very Low Birth Weight Infants

Not Applicable

Terminated

• Conditions: Intraventricular Hemorrhage; Very Low Birth Weight Infants; Premature Infants
• Interventions: Procedure: Delayed cord clamping at 60 seconds; Procedure: Delayed cord clamping at 30 seconds

• Registration Number: NCT02337088
• Lead Sponsor: University of Chicago

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Study Start: 2015-04-16
• Primary Completion: 2017-05-17
• Status Verified: 2017-08
• Study Completion: 2017-08-28
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60 seconds	Delayed cord clamping at 60 seconds	For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery.
30 seconds	Delayed cord clamping at 30 seconds	For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery.

Primary Outcome Measures

Name	Time	Method
Intraventricular hemorrhage	During NICU admission up to 6 months	Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States