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Table 4 Sample size requirements for the primary outcome

From: The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation

Power

Failure rate in non-synchronized NIPPV arm

Failure rate in NIV-NAVA arm

GSD sample size

ICC

Design effect

Sample size (total infants randomized)

90%

30%

15%

358

0.4

1.10

402

0.6

1.15

422

20%

844

0.4

1.10

948

0.6

1.15

992

35%

15%

222

0.4

1.10

250

0.6

1.15

262

20%

406

0.4

1.10

456

0.6

1.15

478

40%

15%

154

0.4

1.10

174

0.6

1.15

182

20%

246

0.4

1.10

278

0.6

1.15

290