NCT02337088

Delayed Cord Clamping in Very Low Birth Weight Infants

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Very Low Birth Weight Infants
• Premature Infants
• Intraventricular Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Delayed cord clamping at 30 seconds	For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery
PROCEDURE	Delayed cord clamping at 60 seconds	For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery

Timeline

• Start date: 2015-04-16
• Primary completion: 2017-05-17
• Completion: 2017-08-28
• First posted: 2015-01-13
• Last updated: 2017-08-29

Locations

1 site across 1 country: United States