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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Drug: 60% Oxygen Group - Infants will start in 60% oxygen; Drug: 30% Oxygen Group - Infants will start in 30% oxygen

• Study Type: Interventional
• Enrollment (Estimated): 1520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Fray; Phone Number: 7807354647; Email: caroline.fray@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
      • Contact: Georg SCHMOLZER; Phone Number: 7807354647; Email: georg.schmoelzer@me.com
      • Principal Investigator: Georg Schmolzer
      • Sub-Investigator: Caroline Fray
      • Sub-Investigator: Brenda Law
      • Contact: Caroline Fray; Phone Number: 7807354647; Email: caroline.fray@albertahealthservices.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial use of 60% oxygen during breathing support in the delivery room; 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: 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.; Other Names: 60% Oxygen Group
Active Comparator: Initial use of 30% oxygen during breathing support in the delivery room; 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.	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.; Other Names: 30% Oxygen Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for ongoing respiratory support at one hour after birth	Ongoing respiratory support will be defined as: the need for intubation and mechanical ventilation or the use of any non-invasive respiratory supports (e.g., CPAP, nasal high flow therapy or low flow oxygen) after initial resuscitation	first 60 minutes after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality in the delivery room	Preterm infants who do not survive the resuscitation at birth	first 60 minutes after birth
Mortality prior discharge	Preterm infants who do not survive during the admission to the neonatal intensive care unit	up to 100 days after birth
Duration of hospital stay	duration in days the preterm infant will be admitted to the neonatal intensive care unit	up to 100 days
Air leak	Air leak defined as pneumothorax	first 72 hours after birth

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Georg Schmolzer, University of Alberta

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Inorganic Chemicals; Elements; Chalcogens; Gases; Oxygen
• Other Study ID Numbers: Pro00146615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: there is no current plan, however requests can be send to Prof. Georg Schmolzer via schmolze@ualberta.ca.

IPD Sharing Time Frame

The Study Protocol and the Statistical Analysis Plan (SAP) will be published during the recruitment phase of the trial.

Informed Consent Form (ICF) and Clinical Study Report (CSR) can be requested from Prof. Georg Schmolzer via schmolze@ualberta.ca

• IPD Sharing Access Criteria: Requests can be send to Prof. Georg Schmolzer via schmolze@ualberta.ca
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No