Oxygen Concentration for Premature Birth
(OXY-PREEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal oxygen level for helping preterm babies, born between 32 and 35 weeks, breathe after birth. Researchers are comparing two oxygen levels—60% and 30%—to identify which one stabilizes breathing without additional support. The trial seeks babies in this age range who need breathing assistance at birth and have no major birth defects. By studying over 1,100 babies in Alberta, Canada, the researchers aim to improve care for infants born slightly early. As an unphased trial, this study provides a unique opportunity to contribute to essential research that could enhance care for preterm infants.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether participants need to stop taking their current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the amount of oxygen given to preterm babies immediately after birth is crucial for their health. Studies have found that excessive oxygen can harm organs, while insufficient oxygen also poses risks. Specifically, some research suggests that higher oxygen levels might damage organs in very premature infants, prompting doctors to use caution.
Conversely, lower oxygen levels can reduce bodily stress and lower the risk of certain lung problems. However, it remains unclear if these lower levels are optimal for babies born slightly early, between 32 and 35 weeks. Some early findings suggest that using 30% oxygen might not help babies reach healthy oxygen levels quickly enough.
In summary, while both high and low oxygen levels have advantages and disadvantages, the study aims to find the safest approach for preterm babies. Determining the right amount of oxygen is crucial, as it can affect the baby's breathing and overall health.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how different oxygen concentrations might impact the health of premature infants during those crucial first minutes after birth. Unlike current practices that might not specify an exact starting oxygen level, this study compares the effects of starting with 60% versus 30% oxygen. The trial aims to find out which concentration better supports stable oxygen levels in premature babies, potentially leading to improved guidelines for their initial care. By understanding the optimal oxygen concentration, the goal is to enhance the immediate and long-term health outcomes of these vulnerable infants.
What evidence suggests that this trial's oxygen therapy treatments could be effective for premature birth?
This trial will compare the effects of starting with different oxygen concentrations for preterm babies. Participants in one arm will receive an initial inspired oxygen concentration of 60% during breathing support in the delivery room. Research has shown that starting with 60% oxygen helps some preterm babies reach healthy oxygen levels within 5 minutes after birth. However, excessive oxygen can harm their developing organs.
In another arm, participants will receive an initial inspired oxygen concentration of 30%. Early data suggests that 30% oxygen might not help some babies reach the needed oxygen levels quickly enough. Studies have not shown a clear difference in survival rates between starting with 30% or 60% oxygen, but experts recommend closely monitoring and adjusting oxygen levels to avoid risks. Finding the right balance of oxygen is crucial for reducing the risk of death and supporting brain development.15678Who Is on the Research Team?
Georg Schmolzer
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
This trial is for late-preterm infants born between 32 and 35 weeks of gestation. The study aims to include over 1,100 babies in Alberta, Canada hospitals. Specific inclusion or exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Infants receive initial oxygen concentration (FiO2 0.6, FiO2 0.3, or FiO2 0.21) during breathing support in the delivery room
Ongoing Respiratory Support
Assessment of need for ongoing respiratory support within the first hour after birth
Follow-up
Monitoring of mortality and other outcomes during NICU stay
What Are the Treatments Tested in This Trial?
Interventions
- Oxygen Therapy
Trial Overview
The study is testing three different initial oxygen levels for preterm babies right after birth: a low level (30% oxygen), a higher level (60% oxygen), and regular air (21% oxygen). It seeks to determine which level helps these infants breathe better with less need for ongoing support.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Citations
Optimizing oxygen therapy for preterm infants at birth
The meta-analysis found no difference in mortality or other clinical outcome when resuscitation was initiated with low oxygen (21–30%) or with high oxygen (60– ...
Oxygen therapy in preterm infants: recommendations for ...
In the absence of definitive data, experts recommend aiming for a SpO2 of at least 80% at 5 minutes of age, as there is an association with increased mortality ...
Oxygen Saturation and Outcomes in Preterm Infants
Targeting an oxygen saturation below 90% with the use of current oximeters in extremely preterm infants was associated with an increased risk of death.
Initial Oxygen Concentration for the Resuscitation of Infants ...
Conclusions and Relevance High initial FiO2 (≥0.90) may be associated with reduced mortality in preterm infants born at less than 32 weeks' ...
Is There a “Right” Amount of Oxygen for Preterm Infant ...
The amount of oxygen given to babies within the first 10 min of life is a crucial factor in determining outcomes, including death and neurodevelopmental injury.
6.
sydney.edu.au
sydney.edu.au/news-opinion/news/2024/06/25/how-much-oxygen-do-very-premature-babies-need-after-birth.htmlHow much oxygen do very premature babies need after birth
Giving very premature babies high concentrations of oxygen soon after birth may reduce the risk of death by 50 percent, compared to lower levels ...
Controversies in oxygen treatment in the delivery room for ...
Key Content and Findings: Very preterm infants (<32 weeks GA) may have less mortality when higher FiO2 (0.90–1.0) is used compared to low (0.21– ...
Aspects on Oxygenation in Preterm Infants before ...
Oxygen is crucial for life but too little (hypoxia) or too much (hyperoxia) may be fatal or cause lifelong morbidity.
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