Not currently recruiting at UC Health

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

a study on Intraventricular Hemorrhage Premature Infant

Summary

Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
Mark Underwood, MD (ucdavis)

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Intraventricular Hemorrhage Umbilical Cord Clamping Extremely Preterm Infants Hemorrhage VentFirst 120 Seconds Cord Clamping

Eligibility

You can join if…

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

You CAN'T join 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.

Locations

  • University of California, Davis not yet accepting patients
    Sacramento California 95817 United States
  • Oregon Health & Science University accepting new patients
    Portland Oregon 37239-0000 United States

Lead Scientist at UC Health

  • Mark Underwood, MD (ucdavis)
    Professor, General Pediatrics. Authored (or co-authored) 104 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Virginia
ID
NCT02742454
Phase
Phase 3
Study Type
Interventional
Last Updated