Clinical Trial

Initial Oxygen Concentration at Birth in Late-Preterm Infants

Study acronym: OXY-PREEM
Not Yet Recruiting
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Summary
This study is aims to examine the best amount of oxygen to give preterm babies (born between 32 and 35 weeks) right after birth. In the past, doctors used high levels of oxygen, but research has shown that using lower levels might help reduce the risk of death in full-term babies without harming brain development. However, investigators don't know the best oxygen level for babies born a little early (32 to 35 weeks). Some early data suggests that giving lower oxygen levels (FiO2 0.3) may not help babies reach healthy oxygen levels by 5 minutes after birth. This study will compare two oxygen levels-FiO2 0.6 and FiO2 0.3 to see which helps babies breathe better and need less ongoing breathing support. Researchers will study over 1,500 babies in hospitals across Alberta, Canada, to find the safest approach for these babies.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-05-05
Trial Details
NCT Number NCT07315594
Lead Sponsor University of Alberta
Conditions Preterm Birth
Enrollment 1,520 participants
Start Date 2026-07-01
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-04