NCT01222364

Delayed Cord Clamping in VLBW Infants

Delayed Cord Clamping in VLBW Infants Pilot Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 1 Minute
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Standard Cord Clamping	Immediate clamping (\<5 seconds) of the umbilical cord after delivery.
PROCEDURE	Delayed Cord Clamping	Clamping of the umbilical cord at 30-45 seconds after birth.

Timeline

• Start date: 2000-06-01
• Primary completion: 2000-12-01
• Completion: 2000-12-01
• First posted: 2010-10-18
• Last updated: 2017-09-26

Locations

4 sites across 1 country: United States