Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks
DUC
1 other identifier
interventional
296
1 country
1
Brief Summary
The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping. Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2007
Typical duration 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
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 21, 2007
CompletedFirst Posted
Study publicly available on registry
November 22, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 22, 2007
November 1, 2007
November 21, 2007
November 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
3 years
Secondary Outcomes (1)
Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.
3 years
Study Arms (2)
A 1
EXPERIMENTALDelayed umbilical cord clamping 30-45 seconds.
A 2
NO INTERVENTIONImmediate umbilibcal cord clamping
Interventions
Eligibility Criteria
You may qualify if:
- Women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation.
- Singleton pregnancy (Note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study).
You may not qualify if:
- Moderate to life threatening fetal anomalies
- Multiple live gestations at birth (e.g. twins, triplets, etc)
- Intrauterine fetal demise
- Previous participation
- Stem cell collection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Related Publications (1)
Chu KS, Shah PS, Whittle WL, Windrim R, Murphy KE. The "DUC" trial: a pilot randomized controlled trial of immediate versus delayed cord clamping in preterm infants born between 24 and 32 weeks gestation. J Matern Fetal Neonatal Med. 2021 Dec;34(24):4049-4052. doi: 10.1080/14767058.2019.1702959. Epub 2019 Dec 25.
PMID: 31875737DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kellie E Murphy, MD MSc
Mount Sinai Hospital, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 21, 2007
First Posted
November 22, 2007
Study Start
November 1, 2007
Study Completion
November 1, 2010
Last Updated
November 22, 2007
Record last verified: 2007-11