Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
54 participants
INTERVENTIONAL
2000-06-30
2000-12-31
Brief Summary
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Detailed Description
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This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Cord Clamping
Standard Cord Clamping
Immediate clamping (\<5 seconds) of the umbilical cord after delivery.
Delayed Cord Clamping
Delayed Cord Clamping
Clamping of the umbilical cord at 30-45 seconds after birth.
Interventions
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Standard Cord Clamping
Immediate clamping (\<5 seconds) of the umbilical cord after delivery.
Delayed Cord Clamping
Clamping of the umbilical cord at 30-45 seconds after birth.
Eligibility Criteria
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Inclusion Criteria
* Singletons
* Obstetrician approval for enrollment
* Parental consent
Exclusion Criteria
* Intent to withhold or withdraw care
* Significant bleeding due to placenta previa or abruption
1 Minute
ALL
Yes
Sponsors
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National Center for Research Resources (NCRR)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Brown University, Women & Infants Hospital of Rhode Island
Principal Investigators
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William Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Avroy A. Fanaroff, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies and Children's Hospital
Edward F. Donovan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Waldemar A. Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama
Birmingham, Alabama, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Countries
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Related Links
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NICHD Neonatal Research Network
Other Identifiers
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NICHD-NRN-0023
Identifier Type: -
Identifier Source: org_study_id