VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
NCT ID: NCT02742454
Last Updated: 2023-10-30
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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UNKNOWN
NA
570 participants
INTERVENTIONAL
2016-06-30
2023-12-31
Brief Summary
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Detailed Description
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The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7.
The study was designed to test the impact of the intervention in each of two cohorts:
1. Infants not breathing well 30 seconds after birth
2. Infants breathing well 30 seconds after birth
Randomization and analysis is stratified by gestational age category:
1. 23 0/6 to 25 6/7 weeks' gestation
2. 26 0/7 to 28 6/7 weeks' gestation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard 30-60 Seconds Cord Clamping
Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping.
Standard 30-60 Seconds Cord Clamping
The infant is stimulated to breathe after birth. If the infant is not breathing well, the cord is clamped at 30 seconds. If the baby is breathing well, the cord is clamped at 60 seconds. Ventilatory assistance is given after cord clamping.
VentFirst 120 Seconds Cord Clamping
Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds.
VentFirst 120 Seconds Cord Clamping
The infant is stimulated to breathe after birth. If the infant is not breathing well, PPV by face mask is given starting at 30 seconds. If the baby is breathing well, CPAP is given starting at 30 seconds. The cord is clamped at 120 seconds.
Interventions
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Standard 30-60 Seconds Cord Clamping
The infant is stimulated to breathe after birth. If the infant is not breathing well, the cord is clamped at 30 seconds. If the baby is breathing well, the cord is clamped at 60 seconds. Ventilatory assistance is given after cord clamping.
VentFirst 120 Seconds Cord Clamping
The infant is stimulated to breathe after birth. If the infant is not breathing well, PPV by face mask is given starting at 30 seconds. If the baby is breathing well, CPAP is given starting at 30 seconds. The cord is clamped at 120 seconds.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Suspected severe fetal anemia
* Monochorionic or monoamniotic twins
* Multiple gestation greater than twins
* Decision made for comfort care only
* Medical emergency necessitating emergency delivery (e.g. complete placental abruption)
* Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.
ALL
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Mayo Clinic
OTHER
St. Louis University
OTHER
University of Colorado, Denver
OTHER
Oregon Health and Science University
OTHER
University of Calgary
OTHER
Columbia University
OTHER
Indiana University
OTHER
University of California, Davis
OTHER
University of Alberta
OTHER
University of Alabama at Birmingham
OTHER
University of Virginia
OTHER
Responsible Party
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Karen Fairchild, MD
Professor of Pediatrics
Principal Investigators
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Karen Fairchild, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Davis
Sacramento, California, United States
University of Colorado
Denver, Colorado, United States
University of Indiana
Indianapolis, Indiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Louis University
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Virginia
Charlottesville, Virginia, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta, Edmonton
Edmonton, Alberta, Canada
Countries
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References
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Fairchild KD, Petroni GR, Varhegyi NE, Strand ML, Josephsen JB, Niermeyer S, Barry JS, Warren JB, Rincon M, Fang JL, Thomas SP, Travers CP, Kane AF, Carlo WA, Byrne BJ, Underwood MA, Poulain FR, Law BH, Gorman TE, Leone TA, Bulas DI, Epelman M, Kline-Fath BM, Chisholm CA, Kattwinkel J; VentFirst Consortium. Ventilatory Assistance Before Umbilical Cord Clamping in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2411140. doi: 10.1001/jamanetworkopen.2024.11140.
Other Identifiers
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18783
Identifier Type: -
Identifier Source: org_study_id
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