Delayed Cord Clamping in VLBW Infants
7 other identifiers
interventional
54
1 country
4
Brief Summary
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2000
Shorter than P25 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
October 14, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedSeptember 26, 2017
September 1, 2017
6 months
October 14, 2010
September 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infants enrolled
Number of infants enrolled in the pilot within 6 months.
6 months
Secondary Outcomes (5)
Intention to treat
6 months
Hematocrit level
4 hours of age
Arterial blood pressure
12 hours of age
Use of volume expansion or pressor therapy
24 hours of age
Blood transfusions
Until hospital discharge or 120 days of life
Study Arms (2)
Standard Cord Clamping
ACTIVE COMPARATORDelayed Cord Clamping
EXPERIMENTALInterventions
Immediate clamping (\<5 seconds) of the umbilical cord after delivery.
Clamping of the umbilical cord at 30-45 seconds after birth.
Eligibility Criteria
You may qualify if:
- Infants born at participating centers at 24-27 weeks gestation
- Singletons
- Obstetrician approval for enrollment
- Parental consent
You may not qualify if:
- Prenatally diagnosed major congenital anomalies
- Intent to withhold or withdraw care
- Significant bleeding due to placenta previa or abruption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Alabama
Birmingham, Alabama, 35249-7335, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Oh, MD
Brown University, Women & Infants Hospital of Rhode Island
- PRINCIPAL INVESTIGATOR
Avroy A. Fanaroff, MD
Case Western Reserve University, Rainbow Babies and Children's Hospital
- PRINCIPAL INVESTIGATOR
Edward F. Donovan, MD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Waldemar A. Carlo, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
October 14, 2010
First Posted
October 18, 2010
Study Start
June 1, 2000
Primary Completion
December 1, 2000
Study Completion
December 1, 2000
Last Updated
September 26, 2017
Record last verified: 2017-09