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Clinical Trials/NCT00562536
NCT00562536
Unknown
Not Applicable

Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial

Mount Sinai Hospital, Canada1 site in 1 country296 target enrollmentNovember 2007
ConditionsPremature Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
Mount Sinai Hospital, Canada
Enrollment
296
Locations
1
Primary Endpoint
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
November 2010
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis

Time Frame: 3 years

Secondary Outcomes

  • Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.(3 years)

Study Sites (1)

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