Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks (DUC)
Primary Purpose
Premature Birth
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Umbilical cord clamping
Sponsored by

About this trial
This is an interventional treatment trial for Premature Birth focused on measuring Umbilical cord clamping, Preterm infants, Randomized controlled trial, For women giving birth to singleton infants 32 weeks gestational age or less
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Moderate to life threatening fetal anomalies
- Multiple live gestations at birth (e.g. twins, triplets, etc)
- Intrauterine fetal demise
- Previous participation
- Stem cell collection
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A 1
A 2
Arm Description
Delayed umbilical cord clamping 30-45 seconds.
Immediate umbilibcal cord clamping
Outcomes
Primary Outcome Measures
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
Secondary Outcome Measures
Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.
Full Information
NCT ID
NCT00562536
First Posted
November 21, 2007
Last Updated
November 21, 2007
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00562536
Brief Title
Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks
Acronym
DUC
Official Title
Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Umbilical cord clamping, Preterm infants, Randomized controlled trial, For women giving birth to singleton infants 32 weeks gestational age or less
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
296 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A 1
Arm Type
Experimental
Arm Description
Delayed umbilical cord clamping 30-45 seconds.
Arm Title
A 2
Arm Type
No Intervention
Arm Description
Immediate umbilibcal cord clamping
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord clamping
Intervention Description
Delay of umbilical cord clamping 30 to 45 seconds
Primary Outcome Measure Information:
Title
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
Moderate to life threatening fetal anomalies
Multiple live gestations at birth (e.g. twins, triplets, etc)
Intrauterine fetal demise
Previous participation
Stem cell collection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kellie E. Murphy, MD MSc
Phone
416 586-8570
Email
kmurphy@mtsinai.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Chu, MD
Email
kelly.chu@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kellie E Murphy, MD MSc
Organizational Affiliation
Mount Sinai Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kellie E. Murphy, MD MSc
Phone
416 586-8570
Email
kmurphy@mtsinai.on.ca
First Name & Middle Initial & Last Name & Degree
Kellie E. Murphy, MD MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
31875737
Citation
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.
Results Reference
derived
Learn more about this trial
Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks
We'll reach out to this number within 24 hrs