Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks (DUC)
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|ClinicalTrials.gov 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
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis [ Time Frame: 3 years ]
- Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia. [ Time Frame: 3 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT00562536
|Contact: Kellie E. Murphy, MD MSc||416 email@example.com|
|Contact: Kelly Chu, MDfirstname.lastname@example.org|
|Mount Sinai Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Kellie E. Murphy, MD MSc 416 586-8570 email@example.com|
|Principal Investigator: Kellie E. Murphy, MD MSc|
|Principal Investigator:||Kellie E Murphy, MD MSc||Mount Sinai Hospital, Canada|