NCT07315594

Initial Oxygen Concentration at Birth in Late-Preterm Infants

Cluster Randomized Trial of Initial Oxygen Concentration at Birth in Late-Preterm Infants

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,520 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 0 Minutes – 10 Minutes
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DRUG	60% Oxygen Group - Infants will start in 60% oxygen	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.
DRUG	30% Oxygen Group - Infants will start in 30% oxygen	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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2029-06-30
• Completion: 2029-12-31
• First posted: 2026-01-02
• Last updated: 2026-01-20

Locations

1 site across 1 country: Canada