Preterm BirthOXY-PREEMNCT07315594
Initial Oxygen Concentration at Birth in Late-Preterm Infants
A study testing 60% Oxygen Group - Infants will start in 60% oxygen and 30% Oxygen Group - Infants will start in 30% oxygen in people with Preterm Birth, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 10 minutes
- Conditions the study is for
- Preterm Birth
- What is being tested?
- 60% Oxygen Group - Infants will start in 60% oxygen and 30% Oxygen Group - Infants will start in 30% oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,520 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 10 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- i) Infant born outside of study centers and transported to centers after delivery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Georg SCHMOLZER, 7807354647, georg.schmoelzer@me.com
Caroline Fray, 7807354647, caroline.fray@albertahealthservices.ca
About this study
Official title: 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.
- Conditions
- Preterm Birth
- Being tested
- 60% Oxygen Group - Infants will start in 60% oxygen, 30% Oxygen Group - Infants will start in 30% oxygen
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60% Oxygen Group - Infants will start in 60% oxygenDrug
Also called 60% Oxygen Group
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.
30% Oxygen Group - Infants will start in 30% oxygenDrug
Also called 30% Oxygen Group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 30% Oxygen Group - Infants will start in 30% oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: first 60 minutes after birth
Secondary outcomes (4)
Mortality in the delivery room
Preterm infants who do not survive the resuscitation at birth
Measured: first 60 minutes after birth
Mortality prior discharge
Preterm infants who do not survive during the admission to the neonatal intensive care unit
Measured: 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
Measured: up to 100 days
Air leak
Air leak defined as pneumothorax
Measured: first 72 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a cluster-crossover design, unmasked randomized controlled trial (RCT) comparing two oxygen concentrations at initiation of resuscitation.
- Masking
- None (open label)
- Enrolment
- 1,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Schmolzer, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315594
- Sponsor's protocol ID
- Pro00146615
- Acronym
- OXY-PREEM
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is no current plan, however requests can be send to Prof. Georg Schmolzer via schmolze@ualberta.ca.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of Initial Oxygen Concentration at Birth in Late-Preterm Infants
- ClinicalTrials.gov ID
- NCT07315594
- Acronym / sponsor ID
- OXY-PREEM / Pro00146615
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,520 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a cluster-crossover design, unmasked randomized controlled trial (RCT) comparing two oxygen concentrations at initiation of resuscitation.
| Arm | Type | Receives |
|---|---|---|
| Initial use of 60% oxygen during breathing support in the delivery room | Experimental | Drug: 60% Oxygen Group - Infants will start in 60% oxygenInfants 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. |
| Initial use of 30% oxygen during breathing support in the delivery room | Active comparator | Drug: 30% Oxygen Group - Infants will start in 30% oxygenInfants 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. |
Who may qualify
- Ages
- 0 to 10 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- i) Infant born outside of study centers and transported to centers after delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60% Oxygen Group - Infants will start in 60% oxygenAlso: 60% Oxygen GroupInfants 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 | Initial use of 60% oxygen during breathing support in the delivery room |
| 30% Oxygen Group - Infants will start in 30% oxygenAlso: 30% Oxygen GroupInfants 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 | Initial use of 30% oxygen during breathing support in the delivery room |
Primary outcome
Need for ongoing respiratory support at one hour after birth
Time frame: first 60 minutes 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
4 secondary outcomes
Mortality in the delivery room
Time frame: first 60 minutes after birth
Mortality prior discharge
Time frame: up to 100 days after birth
Duration of hospital stay
Time frame: up to 100 days
Air leak
Time frame: first 72 hours after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. there is no current plan, however requests can be send to Prof. Georg Schmolzer via schmolze@ualberta.ca.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georg Schmolzer principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60% Oxygen Group - Infants will start in 60% oxygen and 30% Oxygen Group - Infants will start in 30% oxygen in people with Preterm Birth, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Fray (7807354647, caroline.fray@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for ongoing respiratory support at one hour after birth (time frame: first 60 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.