Nasal continuous positive airway pressure (nCPAP) for term neonates with respiratory distress

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:

  1. Age of infant at randomisation (< 6 hours, 6 to 12 hours, > 12 hours to 24 hours)
  2. Setting (neonatal intensive care unit; non-tertiary special care nursery)
  3. Level of continuing distending pressure used (≤ 5 cm H₂0; ≥ 6 cm H₂0)
  4. Types of nCPAP (via continuous flow e.g. bubble nCPAP; variable flow nCPAP e.g. Infant Flow Driver)
  5. Delivery system (nasal cannulae (short); nasal cannulae (long); nasal mask)
  6. Method of oxygen delivery (ambient oxygen (crib, headbox); low-flow nasal cannulae; high-flow nasal cannulae)
  7. Method of birth (caesarean section; vaginal delivery)
  8. Reason for respiratory distress (e.g. hyaline membrane disease; transient tachypnoea of the newborn; bacterial pneumonia; meconium aspiration syndrome; persistent pulmonary hypertension).
Sensitivity analysis

This is a protocol.

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