Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

Not Applicable

Recruiting

• Conditions: Neonatal Respiratory Distress
• Interventions: Procedure: Volume targeted ventilation; Procedure: Pressure targeted ventilation

• Registration Number: NCT05144724
• Lead Sponsor: University of Alberta

Brief Summary

This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room.

Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Study Start: 2024-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Born between 23+0/7 to 28+6/7 weeks' gestation
• Considered suitable for full resuscitation, i.e., no parental request or antenatal decision to forego resuscitation
• Informed parental consent

Exclusion Criteria

• Major congenital or chromosomal malformation
• Conditions that might have an adverse effect on breathing or ventilation (e.g., high risk for lung hypoplasia, congenital diaphragmatic hernia)
• Congenital heart disease requiring intervention in the neonatal period
• Hydrops requiring intervention in the neonatal period
• Neonatal resuscitation initiated before NICU team arrival
• Infants who are born outside of study center and transported to center after delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volume Targeted Ventilation	Volume targeted ventilation	Positive pressure ventilation will be provided using a set tidal volume
Pressure guided Ventilation	Pressure targeted ventilation	Positive pressure ventilation will be provided using a set peak inflation pressure

Primary Outcome Measures

Name	Time	Method
Percentage of of eligible participants (=infants requiring PPV) who have the intervention performed correctly without protocol deviation (=cross over to control group when randomized to VTV-group)	Through study completion (total 18 months)	Percentage of Participants who have received allocated treatment

Trial Locations

Locations (1)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada