CompletedNot Applicable

Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

Canada52 participantsStarted 2024-10-01

Plain-language 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

Who can participate

Age range0 Minutes – 1 Minute

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

Timeframe: Through study completion (total 18 months)

Trial details

NCT IDNCT05144724

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Neonatal Respiratory Distress trials