Initial Oxygen Concentration at Birth in Late-Preterm Infants

Official title

Cluster Randomized Trial of Initial Oxygen Concentration at Birth in Late-Preterm Infants

Overview

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

• Drug 60% 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 oxy
• Drug 30% 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 oxy

Primary outcome measures

• Need for ongoing respiratory support at one hour after birth [Time frame: first 60 minutes after birth]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Royal Alexandra Hospital — Edmonton

Identifiers

NCT: NCT07315594 · Pro00146615

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗