NCT07315594

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,520

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

December 18, 2025

Last Update Submit

April 28, 2026

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Mortality in the delivery room

    first 60 minutes after birth

  • Mortality prior discharge

    up to 100 days after birth

  • Duration of hospital stay

    up to 100 days

  • Air leak

    first 72 hours after birth

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

60% Oxygen Group - Infants will start in 60% oxygenDRUG

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.

Also known as: 60% Oxygen Group
Initial use of 60% oxygen during breathing support in the delivery room
30% Oxygen Group - Infants will start in 30% oxygenDRUG

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.

Also known as: 30% Oxygen Group
Initial use of 30% oxygen during breathing support in the delivery room

Eligibility Criteria

Age0 Minutes - 10 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Georg Schmolzer

    University of Alberta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Fray

CONTACT

7807354647caroline.fray@albertahealthservices.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding will not be feasible, as each center will be assigned to each study intervention and then switch to the second intervention group. However, the trial statistician and DSMB will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This will be a cluster-crossover design, unmasked randomized controlled trial (RCT) comparing two oxygen concentrations at initiation of resuscitation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 2, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

there is no current plan, however requests can be send to Prof. Georg Schmolzer via schmolze@ualberta.ca.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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
Access Criteria
Requests can be send to Prof. Georg Schmolzer via schmolze@ualberta.ca

Locations

CA(1)