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Initial Oxygen Concentration at Birth in Late-Preterm Infants

ConditionPreterm Birth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-10
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 60% Oxygen Group - Infants will start in 60% oxygen

    Drug

    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% oxygen

    Drug

    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 groups

1,520 Participants
are divided into 2 treatment groups
Group A: Initial use of 60% oxygen during breathing support in the delivery roomExperimental treatment 1 intervention
Group B: Initial use of 30% oxygen during breathing support in the delivery roomActive comparator 1 intervention

Trial outcomes

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

Time frame
first 60 minutes after birth

Secondary outcomes

1

Mortality in the delivery room

Preterm infants who do not survive the resuscitation at birth

Time frame
first 60 minutes after birth
2

Mortality prior discharge

Preterm infants who do not survive during the admission to the neonatal intensive care unit

Time frame
up to 100 days after birth
3

Duration of hospital stay

duration in days the preterm infant will be admitted to the neonatal intensive care unit

Time frame
up to 100 days
4

Air leak

Air leak defined as pneumothorax

Time frame
first 72 hours after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: