NCT02742454

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 570 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Intraventricular Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Standard 30-60 Seconds Cord Clamping	The infant is stimulated to breathe after birth. If the infant is not breathing well, the cord is clamped at 30 seconds. If the baby is breathing well, the cord is clamped at 60 seconds. Ventilatory assistance is given after cord clamping.
PROCEDURE	VentFirst 120 Seconds Cord Clamping	The infant is stimulated to breathe after birth. If the infant is not breathing well, PPV by face mask is given starting at 30 seconds. If the baby is breathing well, CPAP is given starting at 30 seconds. The cord is clamped at 120 seconds.

Timeline

• Start date: 2016-06-01
• Primary completion: 2023-03-01
• Completion: 2023-12-01
• First posted: 2016-04-19
• Last updated: 2023-10-30

Locations

12 sites across 2 countries: United States, Canada