Table 3.
Primary and secondary outcomes.
| Primary outcome | Usual diet + RUTF | Usual diet | Effect estimate (95% CI) | p value |
|---|---|---|---|---|
| Primary composite endpoint | 0.50 (0.00, 1.00) [397] | 0.50 (0.00, 1.00) [397] | 0.49 (0.45, 0.53)a | 0.740b |
| Components of the primary outcome | ||||
| Change in MUAC 90 d—baselinec | 0.54 (0.85) [384] | 0.55 (0.81) [383] | −0.02 (−0.13, 0.10)d | |
| Mortality by day 90 | 13/420 (3.1%) | 14/421 (3.3%) | 1.00 (0.46, 2.15)e | |
| Secondary outcomes | ||||
| Mortality by day 28 | 7/421 (1.7%) | 10/421 (2.4%) | 0.79 (0.29, 2.12)e | |
| Mortality by day 180 | 15/418 (3.6%) | 18/416 (4.3%) | 0.87 (0.44, 1.75)e | |
| Any hospital readmissions before 28 daysf | 17/407 (4.2%) | 8/405 (2.0%) | 2.2 (−0.2, 4.6)g | |
| Any hospital readmissions before 180 daysf | 54/387 (14.0%) | 37/375 (9.9%) | 4.1 (−0.5, 8.7)g | |
| Neurocognitive disability at 28 daysf | 7/120 (5.8%) | 4/120 (3.3%) | 2.5 (−2.8, 7.8)g | |
| Persisting neurocognitive disability at 90 daysf | 3/7 (42.9%) | 3/4 (75.0%) | −32.1 (−88.2, 23.9)g | |
| Length of initial hospital stay, elapsed calendar days (in survivors) | 3.0 (3.5) [419] | 2.9 (3.0) [414] | −0.01 (−0.42, 0.41)d | |
| MUAC-for-age z-scoref | ||||
| at 28 days | 0.1 (1.1) [352] | 0.0 (1.1) [350] | 0.03 (−0.04, 0.11)d | |
| at 90 days | 0.2 (1.1) [337] | 0.2 (1.1) [330] | 0.01 (−0.08, 0.10)d | |
| at 180 days | 0.2 (1.1) [317] | 0.2 (1.1) [297] | −0.06 (−0.17, 0.06)d | |
| Weight-for-height z-scoref | ||||
| at 28 days | 0.0 (1.3) [350] | −0.0 (1.3) [350] | 0.08 (−0.04, 0.20)d | |
| at 90 days | 0.2 (1.2) [336] | 0.2 (1.3) [328] | −0.00 (−0.14, 0.14)d | |
| at 180 days | 0.3 (1.2) [317] | 0.3 (1.2) [296] | −0.03 (−0.19, 0.12)d | |
| Skinfold-for-age z-scoref | ||||
| at 28 days | 0.1 (1.1) [251] | 0.0 (1.1) [246] | 0.12 (0.03, 0.21)d | |
| at 90 days | 0.2 (1.1) [240] | 0.2 (1.1) [234] | 0.14 (0.02, 0.27)d | |
| at 180 days | 0.3 (1.0) [243] | 0.3 (1.0) [228] | 0.03 (−0.10, 0.17)d |
Data are median (IQR) [N], mean (SD) [N] or n/N (%) unless otherwise indicated.
a
Probabilistic index.
b
Wilcoxon's rank sum test.
c
Calculated among patients alive and not missing MUAC at 90 days.
d
Adjusted mean difference (adjusted for baseline MUAC and trial site as random effect).
e
Adjusted hazard ratio (adjusted for baseline MUAC and trial site as shared frailty).
f
Calculated among patients alive at follow-up timepoint.
g
Absolute risk difference.