Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate
A Randomized Controlled Trial of Immediate Versus Delayed Cord Clamping in the Preterm Neonate
1 other identifier
interventional
200
1 country
1
Brief Summary
To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 18, 2007
CompletedFirst Posted
Study publicly available on registry
December 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJanuary 20, 2012
January 1, 2012
4.6 years
December 18, 2007
January 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.
2 years
Study Arms (2)
A
EXPERIMENTALDelayed Cord Clamping
B
ACTIVE COMPARATORImmediate cord clamping
Interventions
Eligibility Criteria
You may qualify if:
- Singleton pregnancies
- Signed consent to participate in the trial
You may not qualify if:
- Major fetal anomaly or known fetal chromosomal abnormalities
- Multiple gestation
- Mothers with pregestational and gestational diabetes
- Refusal to participate in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Related Publications (1)
Elimian A, Goodman J, Escobedo M, Nightingale L, Knudtson E, Williams M. Immediate compared with delayed cord clamping in the preterm neonate: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1075-1079. doi: 10.1097/AOG.0000000000000556.
PMID: 25415157DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Elimian, MD
University of Oklahoma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2007
First Posted
December 24, 2007
Study Start
October 1, 2006
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 20, 2012
Record last verified: 2012-01