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Table 3 Secondary outcomes

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 or difference of means or difference of medians (95% CI)

Time to desaturation—secondsa

Mean (SD) or median (IQR)

Mean (SD) or median (IQR)

 

Duration of desaturation—secondsa

Mean (SD) or median (IQR)

Mean (SD) or median (IQR)

 

Median SpO2a

Mean (SD) or median (IQR)

Mean (SD) or median (IQR)

 

Bradycardia (HR < 100 bpm)a

XX (%)

XX (%)

 

Time to bradycardia—secondsa

Mean (SD) or median (IQR)

Mean (SD) or median (IQR)

 

Duration of bradycardia—secondsa

Mean (SD) or median (IQR)

Mean (SD) or median (IQR)

 

Median HRa

Mean (SD) or median (IQR)

Mean (SD) or median (IQR)

 

Number of intubation attempts

Mean (SD) or median (IQR)

Mean (SD) or median (IQR)

 

Total duration of all intubation attempts (successful and unsuccessful)—secondsc

Mean (SD) or median (IQR)

Mean (SD) or median (IQR)

 

CPR and/or adrenaline administration within 1 h of intubation attemptb

XX (%)

XX (%)

 

Pneumothorax diagnosed within 72 h after randomisationb

XX (%)

XX (%)

 

 Any

XX (%)

XX (%)

 

 Requiring drainage with needle thoracocentesis or intercostal catheter

XX (%)

XX (%)

 

Death within 72 h after randomisationb

XX (%)

XX (%)

 
  1. aDuring first intubation attempt
  2. bSpecified as serious adverse events in trial
  3. cSum of each separate intubation attempt
  4. IQR interquartile range, SpO2 peripheral oxygen saturation, HR heart rate, Bpm beats per minute, CPR cardiopulmonary resuscitation