To determine whether nCPAP as the primary modality of treatment is effective and safe for treating respiratory distress in the term neonate (≥ 37 weeks gestation).
We will explore potential sources of clinical heterogeneity through the following a priori subgroup analysis:
- Age of infant at randomisation (< 6 hours, 6 to 12 hours, > 12 hours to 24 hours)
- Setting (neonatal intensive care unit; non-tertiary special care nursery)
- Level of continuing distending pressure used (≤ 5 cm H₂0; ≥ 6 cm H₂0)
- Types of nCPAP (via continuous flow e.g. bubble nCPAP; variable flow nCPAP e.g. Infant Flow Driver)
- Delivery system (nasal cannulae (short); nasal cannulae (long); nasal mask)
- Method of oxygen delivery (ambient oxygen (crib, headbox); low-flow nasal cannulae; high-flow nasal cannulae)
- Method of birth (caesarean section; vaginal delivery)
- Reason for respiratory distress (e.g. hyaline membrane disease; transient tachypnoea of the newborn; bacterial pneumonia; meconium aspiration syndrome; persistent pulmonary hypertension).
This is a protocol.