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

Status unconfirmed · Not applicable

Conditions studied: Intraventricular Hemorrhage

In brief

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.

Key facts

Study ID

NCT02742454

Run by

University of Virginia

People needed

570

Starts

2016-06-01

Expected to finish

2023-12-01

Last updated by the study team

2023-10-30

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 23 0/7 - 28 6/7 weeks' gestation at delivery

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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