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Sponsored by: |
Mount Sinai Hospital, Canada |
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Information provided by: | Mount Sinai Hospital, Canada |
ClinicalTrials.gov Identifier: | NCT00562536 |
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 |
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Premature Birth |
Procedure: Umbilical cord clamping |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial |
Estimated Enrollment: | 296 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2010 |
Arms | Assigned Interventions |
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A 1: Experimental
Delayed umbilical cord clamping 30-45 seconds.
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Procedure: Umbilical cord clamping
Delay of umbilical cord clamping 30 to 45 seconds
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A 2: No Intervention
Immediate umbilibcal cord clamping
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Ages Eligible for Study: | 15 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kellie E. Murphy, MD MSc | 416 586-8570 | kmurphy@mtsinai.on.ca |
Contact: Kelly Chu, MD | kelly.chu@utoronto.ca |
Canada, Ontario | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada, M5G 1X5 |
Principal Investigator: | Kellie E Murphy, MD MSc | Mount Sinai Hospital Toronto |
Study ID Numbers: | Mount Sinai Hospital Toronto |
Study First Received: | November 21, 2007 |
Last Updated: | November 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00562536 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Umbilical cord clamping Preterm infants Randomized controlled trial For women giving birth to singleton infants 32 weeks gestational age or less |
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Premature Birth |
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Premature Birth |