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

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.

We found this trial at

sites

University of Virginia

Charlottesville, Virginia 22903

(434) 924-0311