Table E5.
Sample-Size Estimates across Outcomes
| Outcome | Control* (%) | Intervention (%) | Absolute Risk Reduction (%) | Relative Risk Reduction (%) | N per Group | No. PICUs† (1 yr) | No. PICUs† (3 yr) |
|---|---|---|---|---|---|---|---|
| New or progressive MODS | 40 | 35 | 5 | 13 | 1,471 | 245 | 81 |
| 40 | 30 | 10 | 25 | 356 | 59 | 20 | |
| PICU mortality | 24 | 19 | 5 | 21 | 1,059 | 177 | 58 |
| 24 | 14 | 10 | 42 | 241 | 40 | 13 | |
| Hospital mortality | 25 | 20 | 5 | 20 | 1,094 | 182 | 60 |
| 25 | 15 | 10 | 40 | 250 | 42 | 14 | |
| At least mild disability‡ | 28 | 23 | 5 | 18 | 1,192 | 199 | 65 |
| 28 | 18 | 10 | 36 | 277 | 46 | 15 | |
| At least moderate disability§ | 17 | 12 | 5 | 29 | 778 | 130 | 43 |
| 17 | 7 | 10 | 59 | 165 | 28 | 9 | |
| Death or disability|| | 38 | 33 | 5 | 13 | 1,437 | 240 | 79 |
| 38 | 28 | 10 | 26 | 346 | 58 | 19 |
Definition of abbreviations: MODS = multiorgan dysfunction syndrome; PICU = pediatric intensive care unit.
Baseline estimate from SPROUT study.
Number of PICUs required to meet sample size is estimated based on a median of 16 beds per PICU and a median PICU length of stay of 15 days per patient with a 50% consent rate.
Any increase in POPC from baseline to hospital discharge in the 422 hospital survivors.
Discharge POPC ≥ 3 and an increase of at least 1 from baseline in the 422 hospital survivors.
Death or at least moderate disability at hospital discharge.