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NCT02478684 · ClinicalTrials.gov registry record · NA
Delayed Cord Clamping in Preterm Neonates
A NA study of Infant, Very Low Birth Weight and Premature Birth of Newborn, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT02478684 is a NA study of Infant, Very Low Birth Weight and Premature Birth of Newborn that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 105 participants, below the 281-participant average among 4 other Infant, Very Low Birth Weight trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02478684, a NA study of Infant, Very Low Birth Weight and Premature Birth of Newborn, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER 30 Seconds of placental blood transfusion
- OTHER 60 Seconds of placental blood transfusion
Study Locations (1)
New York
- Weill Cornell medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-03-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02478684
The ClinicalTrials.gov registry entry for NCT02478684 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 281-participant average among 4 other Infant, Very Low Birth Weight trials with a reported enrollment target (63% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Infant, Very Low Birth Weight appearing as the primary indexed condition, and to 2 interventions - of which 30 Seconds of placental blood transfusion is the first listed.
NCT02478684 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02478684 about?
NCT02478684 is a clinical study titled "Delayed Cord Clamping in Preterm Neonates". 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 im...
What is the current status of trial NCT02478684?
This trial is currently completed. It is a NA study. The enrollment target is 105 participants. The study started on 2015-07. Estimated completion is 2019-03-30.
What conditions does trial NCT02478684 study?
This clinical trial studies the following conditions: Infant, Very Low Birth Weight, Premature Birth of Newborn, Placental Transfusion, Delayed Separation of Umbilical Cord.
What interventions are being tested in trial NCT02478684?
The interventions under investigation include: 30 Seconds of placental blood transfusion (OTHER), 60 Seconds of placental blood transfusion (OTHER).
Who is sponsoring clinical trial NCT02478684?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02478684 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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