Preterm Birth
Conditions
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.
Interventions
DRUG60% 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.
DRUG30% 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.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
This will be a cluster-crossover design, unmasked randomized controlled trial (RCT) comparing two oxygen concentrations at initiation of resuscitation.
Eligibility
Sex/Gender
ALL
Age
0 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for ongoing respiratory support at one hour after birth | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality in the delivery room | first 60 minutes after birth | Preterm infants who do not survive the resuscitation at birth |
| Mortality prior discharge | up to 100 days after birth | Preterm infants who do not survive during the admission to the neonatal intensive care unit |
| Duration of hospital stay | up to 100 days | duration in days the preterm infant will be admitted to the neonatal intensive care unit |
| Air leak | first 72 hours after birth | Air leak defined as pneumothorax |
Countries
Canada
Contacts
CONTACTCaroline Fray
PRINCIPAL_INVESTIGATORGeorg Schmolzer
University of Alberta
Outcome results
None listed