Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

NCT05144724 | Completed DMC

• 1 other identifier: Pro00115050
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• 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)

  Percentage of Participants who have received allocated treatment

  Through study completion (total 18 months)

Secondary Outcomes (15)

• Number of participants with mortality

  up to 6 months of NICU admission

• Number of participants with severe brain injury on cranial ultrasound

  up to 6 months of NICU admission

• Number of participants with severe retinopathy of prematurity (stage 3 or higher)

  up to 6 months of NICU admission

• Number of participants with bronchopulmonary dysplasia at 36 weeks corrected age

  At 36 weeks corrected age

• Number of participants with Bronchopulmonary dysplasia at 40 weeks corrected age

  At 40 weeks corrected age

Other Outcomes (2)

• Resuscitators subjective workload performing mask ventilation

  within the first 10 min after birth

• Resuscitators qualitative feedback on using VTV-PPV in the delivery room

  within the first 10 min after birth

Study Arms (2)

Volume Targeted Ventilation

EXPERIMENTAL

Positive pressure ventilation will be provided using a set tidal volume

Procedure: Volume targeted ventilation

Pressure guided Ventilation

ACTIVE COMPARATOR

Positive pressure ventilation will be provided using a set peak inflation pressure

Procedure: Pressure targeted ventilation

Interventions

Volume targeted ventilation PROCEDURE

Positive pressure ventilation will be provided using a set tidal volume

Volume Targeted Ventilation

Pressure targeted ventilation PROCEDURE

Positive pressure ventilation will be provided using a set peak inflation pressure

Pressure guided Ventilation

Eligibility Criteria

• Age: 0 Minutes - 1 Minute
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (1)

• Law BHY, Yaskina M, Davis PG, Polglase G, Dunn M, Mukerji A, Schmolzer GM. Study protocol for the volume targeted mask ventilation versus pressure ventilation in preterm infants-the VOLT-trial. Front Pediatr. 2026 Jan 6;13:1743460. doi: 10.3389/fped.2025.1743460. eCollection 2025.

  PMID: 41567425 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Georg Schmölzer, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: December 3, 2021
• Study Start: October 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: December 17, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Protocol will be published within 18 months

Locations

CA (1)