Skip to main content

Table 2 Primary outcome and components

From: The SHINE trial (a multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation): statistical analysis plan

Outcome

Nasal HF group (n = XXX)

Control group (n = XXX)

Risk difference (95% CI)

Intention-to-treat analysis

Successful first attempt intubation without physiological instability

XX (%)

XX (%)

 

 ≤ 28 weeks’ GA

XX (%)

XX (%)

 

 > 28 weeks’ GA

XX (%)

XX (%)

 

 Premedication use

XX (%)

XX (%)

 

 No premedication use

XX (%)

XX (%)

 

 Inexperienced operator (< 20 previous intubations

XX (%)

XX (%)

 

 Experienced operator (≥ 20 previous intubations)

XX (%)

XX (%)

 

Successful first attempt intubation

XX (%)

XX (%)

 

Desaturation (SpO2 > 20% from baseline) during the first intubation attempt

XX (%)

XX (%)

 

Bradycardia (HR < 100 bpm) during the first intubation attempt

XX (%)

XX (%)