CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
30 Seconds of placental blood transfusion +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02478684
NCT02478684N/ACompleted

The Effects of Delayed Cord Clamping on Postnatal Circulatory Status in Preterm Neonates

Weill Medical College of Cornell University·interventional·Posted Jun 23, 2015·Updated Oct 30, 2019

In Brief

A clinical study evaluating 30 Seconds of placental blood transfusion and 60 Seconds of placental blood transfusion for Premature Birth of Newborn and 3 related conditions. Completed, enrolled 105 participants across 1 site.

Detailed Summary

Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the placenta through the umbilical cord to the infant, thus resulting in a placental transfusion. This transfusion may improve circulating volume at birth leading to a smoother postnatal transition and overall improved outcome for preterm infants. The average blood volume delivered with DCC up to 90 seconds in preterm infants has been estimated to be about 12 ml per kg with vaginal deliveries resulting in slightly higher transfusions compared to cesarean deliveries. Several several short-term benefits have been described including a reduction in the need for blood transfusions as well as a possible reduction in intraventricular hemorrhage and necrotizing enterocolitis. All mothers with threatened preterm delivery between 28 and 34 6/7 weeks will be approached for the study. Following consent, the infant will be randomly assigned to either a 30 or 60 second delay in cord clamping in the delivery room. If the infant is not breathing by 30 seconds, the cord will be clamped and the infant moved to a resuscitation area. The primary outcome is a 3 percent difference in the hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 23, 2015
Enrollment StartJul 1, 2015
Primary CompletionMar 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.0 years ago

Interventions

30 Seconds of placental blood transfusionother

By delaying clamping of the cord blood for 30 seconds, blood will be allowed to move from the placenta to the premature infant

60 Seconds of placental blood transfusionother

By delaying clamping of the cord blood for 60 seconds, blood will be allowed to move from the placenta to the premature infant