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

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

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.

Newborns with gestational age 23 wks 0 days through 28 wks 6 days are randomized to control (delayed cord clamping for at least 30 seconds, or up to 60 seconds if breathing spontaneously, with ventilatory assistance provided after) or the VentFirst intervention (ventilatory assistance with continuous positive airway pressure or positive pressure ventilation given starting 30 seconds after birth and cord clamping at 120 seconds).

The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7.

The study was designed to test the impact of the intervention in each of two cohorts:

1. Infants not breathing well 30 seconds after birth
2. Infants breathing well 30 seconds after birth

Randomization and analysis is stratified by gestational age category:

1. 23 0/6 to 25 6/7 weeks' gestation
2. 26 0/7 to 28 6/7 weeks' gestation

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.