- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00562536
Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks (DUC)
Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kellie E. Murphy, MD MSc
- Phone Number: 416 586-8570
- Email: kmurphy@mtsinai.on.ca
Study Contact Backup
- Name: Kelly Chu, MD
- Email: kelly.chu@utoronto.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
Contact:
- Kellie E. Murphy, MD MSc
- Phone Number: 416 586-8570
- Email: kmurphy@mtsinai.on.ca
-
Principal Investigator:
- Kellie E. Murphy, MD MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A 1
Delayed umbilical cord clamping 30-45 seconds.
|
Delay of umbilical cord clamping 30 to 45 seconds
|
No Intervention: A 2
Immediate umbilibcal cord clamping
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kellie E Murphy, MD MSc, Mount Sinai Hospital, Canada
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mount Sinai Hospital Toronto
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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