Oxygen Concentration for Premature Birth
(OXY-PREEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is trying to figure out 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, we 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 three oxygen levels-FiO2 0.6, FiO2 0.3, and air (FiO2 0.21)-to see which helps babies breathe better and need less ongoing breathing support. Researchers will study over 1,100 babies in hospitals across Alberta, Canada, to find the safest approach for these babies.
Who Is on the Research Team?
Georg Schmolzer
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
This trial is for late-preterm infants born between 32 and 35 weeks of gestation. The study aims to include over 1,100 babies in Alberta, Canada hospitals. Specific inclusion or exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Infants receive initial oxygen concentration (FiO2 0.6, FiO2 0.3, or FiO2 0.21) during breathing support in the delivery room
Ongoing Respiratory Support
Assessment of need for ongoing respiratory support within the first hour after birth
Follow-up
Monitoring of mortality and other outcomes during NICU stay
What Are the Treatments Tested in This Trial?
Interventions
- Oxygen Therapy
Trial Overview
The study is testing three different initial oxygen levels for preterm babies right after birth: a low level (30% oxygen), a higher level (60% oxygen), and regular air (21% oxygen). It seeks to determine which level helps these infants breathe better with less need for ongoing support.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Infants randomized to the 60% Oxygen (FiO₂) Group will begin respiratory support with an initial inspired oxygen concentration of 60%. At birth, all infants will receive 60 seconds of delayed cord clamping as standard care. Following cord clamping, a pulse oximeter will be applied to measure peripheral oxygen saturation (SpO₂), with a reliable signal typically available at approximately 3 minutes of age. At 3 minutes of age, the clinical team will assess SpO₂. If SpO₂ is \<85%, the inspired oxygen concentration will be increased by 20% every 60 seconds to achieve an SpO₂ \>85% by 5 minutes of age. If SpO₂ is \>95% at or before 5 minutes of age, the inspired oxygen concentration will be decreased stepwise in increments of 10-20% every 60 seconds to maintain an SpO₂ \>85% between 5 and 10 minutes of age, or an SpO₂ of 90-95% at and beyond 10 minutes of age.
Infants randomized to the 30% Oxygen (FiO₂) Group will begin respiratory support with an initial inspired oxygen concentration of 30%. At birth, all infants will receive 60 seconds of delayed cord clamping as standard care. Following cord clamping, a pulse oximeter will be applied to measure peripheral oxygen saturation (SpO₂), with a reliable signal typically available at approximately 3 minutes of age. At 3 minutes of age, the clinical team will assess SpO₂. If SpO₂ is \<85%, the inspired oxygen concentration will be increased by 20% every 60 seconds to achieve an SpO₂ \>85% by 5 minutes of age. If SpO₂ is \>95% at or before 5 minutes of age, the inspired oxygen concentration will be decreased stepwise in increments of 10-20% every 60 seconds to maintain an SpO₂ \>85% between 5 and 10 minutes of age, or an SpO₂ of 90-95% at and beyond 10 minutes of age.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
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