Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks (DUC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562536
Recruitment Status : Unknown
Verified November 2007 by Mount Sinai Hospital, Canada.
Recruitment status was:  Not yet recruiting
First Posted : November 22, 2007
Last Update Posted : November 22, 2007
Information provided by:
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Premature Birth Procedure: Umbilical cord clamping Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
Study Start Date : November 2007
Estimated Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: A 1
Delayed umbilical cord clamping 30-45 seconds.
Procedure: Umbilical cord clamping
Delay of umbilical cord clamping 30 to 45 seconds
No Intervention: A 2
Immediate umbilibcal cord clamping

Primary Outcome Measures :
  1. Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562536

Contact: Kellie E. Murphy, MD MSc 416 586-8570
Contact: Kelly Chu, MD

Canada, Ontario
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Kellie E. Murphy, MD MSc    416 586-8570   
Principal Investigator: Kellie E. Murphy, MD MSc         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Principal Investigator: Kellie E Murphy, MD MSc Mount Sinai Hospital, Canada Identifier: NCT00562536     History of Changes
Other Study ID Numbers: Mount Sinai Hospital Toronto
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: November 22, 2007
Last Verified: November 2007

Keywords provided by Mount Sinai Hospital, Canada:
Umbilical cord clamping
Preterm infants
Randomized controlled trial
For women giving birth to singleton infants 32 weeks gestational age or less

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications