Table 1.
Demographics of included subjects
| All data | NeoMero-1 | NeoMero-2 | |
|---|---|---|---|
| Number of subjectsa | 167 | 123 | 49 |
| Weight (kg), median (range) | 2.12 (0.48–6.32) | 1.68 (0.48–5.01) | 3.11 (0.60–6.32) |
| GA (weeks), median (range) | 33.3 (22.6–41.9) | 31.9 (22.6–41.3) | 37.1 (23.4–41.9) |
| PNA (days), median (range) | 13 (1–90) | 15 (3–83) | 9 (1–90) |
| Postmenstrual age (weeks), median (range) | 37.4 (23.7–51.3) | 36.0 (23.7–51.3) | 38.8 (24.9–51.1) |
| Female, n (%) | 78 (46.7) | 59 (48.4) | 19 (42.2) |
| Number of plasma samples | 401 | 255 | 147 |
| Plasma samples per patient, mean | 2.4 | 2.1 | 3.0 |
| Number of CSF samples | 78 | 32 | 46 |
| CSF samples per patient, mean | 0.47 | 0.26 | 0.94 |
| Plasma concentration (mg/L), median (range) | 7.94 (0.01–147.7) | 5.27 (0.01–147.7) | 12.4 (0.1–139.0) |
| CSF concentration (mg/L), median (range) | 1.58 (0.04–35.4) | 1.23 (0.04–7.34) | 1.90 (0.05–35.4) |
| Plasma time after the dose (h), median (range) | 5.66 (0–12.4) | 5.93 (0–12.4) | 5.19 (0–12.2) |
| CSF time after the dose (h), median (range) | 5.27 (0–12.0) | 5.99 (0–12.0) | 5.03 (0–11.5) |
| Creatinine (μmol/L), median (range) | 32.0 (3.54–197.4) | 34.5 (3.54–197.4) | 27.0 (6.0–133) |
| C-reactive protein (mg/L), median (range) | 23.0 (0.3–280) | 23.2 (0.3–242) | 22.4 (0.4–280) |
| Procalcitonin (ng/mL), median (range) | 2.7 (0.1–377.2) | 2.8 (0.1–128.6) | 1.8 (0.1–377.2) |
For creatinine, C-reactive protein and procalcitonin, the summary statistics represent all samples recorded during the study.
Day 0 = first day of life.
Weight, PNA and GA–at enrolment.
a
Five infants switched from NeoMero-1 to NeoMero-2.