Initial Oxygen Concentration at Birth in Late-Preterm Infants (OXY-PREEM)

University of Alberta

Status: Begins enrollment in 4 months

Conditions: Preterm Birth

Treatments: Drug: 30% Oxygen Group - Infants will start in 30% oxygen; Drug: 60% Oxygen Group - Infants will start in 60% oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT07315594

Pro00146615

Details and patient eligibility

About

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.

Enrollment: 1,520 estimated patients

Sex: All

Ages: Under 10 minutes old

Volunteers: No Healthy Volunteers

Inclusion criteria

• i) Infants with gestational age between 32+0-35+6 weeks based on best available obstetrical estimate, requiring respiratory support
• ii) Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to provide only comfort care at birth
• iii) No known major congenital or chromosomal malformation.

Exclusion criteria

• i) Infant born outside of study centers and transported to centers after delivery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,520 participants in 2 patient groups

Initial use of 60% oxygen during breathing support in the delivery room

Experimental group

Description:

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.

Treatment:

Drug: 60% Oxygen Group - Infants will start in 60% oxygen

Initial use of 30% oxygen during breathing support in the delivery room

Active Comparator group

Description:

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.

Treatment:

Drug: 30% Oxygen Group - Infants will start in 30% oxygen