VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:2/27/2019
Start Date:June 2016
End Date:June 2023
Contact:Steven A Fowler
Email:SAF2QH@virginia.edu
Phone:(434) 243-4730

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The purpose of this study is to determine whether providing ventilatory assistance prior to
umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in
extremely preterm (EPT) infants, compared to standard care of providing ventilatory
assistance after cord clamping.

940 newborns with gestation 23 wks 0 days through 28 wks 6 days Randomized to Standard arm
(delayed cord clamping for 30 seconds, or up to 60 seconds if breathing spontaneously) or
VentFirst arm (receive CPAP or PPV from 30 sec to 120 sec).

Primary outcome is lack of IVH on 7-10 day head ultrasound.

Inclusion Criteria:

- 23 0/7 - 28 6/7 weeks gestation at delivery.

Exclusion Criteria:

- Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal
abnormality, severe congenital malformation)

- 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.
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Saint Louis, Missouri 63110
Phone: 314-678-2192
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-6626
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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Calgary, Alberta
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Charlottesville, Virginia 22903
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Denver, Colorado 80210
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Indianapolis, Indiana
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-305-8500
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Rochester, Minnesota 55905
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Mark Underwood, MD
Phone: 916-734-8121
University of California-Davis As we begin our second century, UC Davis is poised to become...
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