Comparing two types of ventilation for preterm infants
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
This study is testing which breathing support method works better for preterm infants with breathing problems right after birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Minutes to 1 Minute |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05144724 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the feasibility of using volume targeted ventilation compared to pressure guided ventilation for preterm infants experiencing respiratory distress in the delivery room. Infants born between 23 and 28 weeks of gestation will be randomly assigned to receive one of the two ventilation methods during their initial respiratory support. The study aims to determine which method is more effective in managing the respiratory needs of these vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born between 23+0/7 to 28+6/7 weeks' gestation who are suitable for full resuscitation.
Not a fit: Patients with major congenital malformations or conditions adversely affecting breathing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve respiratory support strategies for preterm infants, potentially leading to better health outcomes.
How similar studies have performed: While this approach is being explored in this pilot trial, similar studies have shown promise in improving ventilation strategies for preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edmonton, Alberta
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Georg Schmölzer, MD, PhD — University of Alberta
- Study coordinator: Georg Schmölzer, MD, PhD
- Email: georg.schmoelzer@me.com
- Phone: +17807354647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.