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

  • STATUS
    Recruiting
  • End date
    Jun 20, 2023
  • participants needed
    940
  • sponsor
    University of Virginia
Updated on 4 October 2022
umbilical cord clamping
Accepts healthy volunteers

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.

Description

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.

Details
Condition Intraventricular Hemorrhage
Treatment Standard 30-60 Seconds Cord Clamping, VentFirst 120 Seconds Cord Clamping
Clinical Study IdentifierNCT02742454
SponsorUniversity of Virginia
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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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