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

University of Virginia

Status: Active, not recruiting

Conditions: Intraventricular Hemorrhage

Treatments: Procedure: Standard 30-60 Seconds Cord Clamping; Procedure: VentFirst 120 Seconds Cord Clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT02742454

18783

Details and patient eligibility

About

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.

Full 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

Enrollment: 570 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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570 participants in 2 patient groups

Standard 30-60 Seconds Cord Clamping

Active Comparator group

Description:

Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping.

Treatment:

Procedure: Standard 30-60 Seconds Cord Clamping

VentFirst 120 Seconds Cord Clamping

Experimental group

Description:

Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds.

Treatment:

Procedure: VentFirst 120 Seconds Cord Clamping