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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Mount Sinai Hospital, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00562536
First received: November 21, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention
Premature Birth
Procedure: Umbilical cord clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

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

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

Estimated Enrollment: 296
Study Start Date: November 2007
Estimated Study Completion Date: November 2010
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562536

Contacts
Contact: Kellie E. Murphy, MD MSc 416 586-8570 kmurphy@mtsinai.on.ca
Contact: Kelly Chu, MD kelly.chu@utoronto.ca

Locations
Canada, Ontario
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Kellie E. Murphy, MD MSc    416 586-8570    kmurphy@mtsinai.on.ca   
Principal Investigator: Kellie E. Murphy, MD MSc         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Kellie E Murphy, MD MSc Mount Sinai Hospital, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562536     History of Changes
Other Study ID Numbers: Mount Sinai Hospital Toronto
Study First Received: November 21, 2007
Last Updated: November 21, 2007
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 24, 2014