Demographic information for study cohorts and for the whole ELFIN and MAGPIE cohorts
| 16S cohort | VOC cohort | LC-MS stool cohort | LC-MS urine cohort | ELFIN cohort | MAGPIE cohort | ||||||||||||
| Lactoferrin | Placebo | P value | Lactoferrin | Placebo | P value | Lactoferrin | Placebo | P value | Lactoferrin | Placebo | P value | Lactoferrin | Placebo | Mean (SD) | All (479) | ||
| Median (IQR) | Gestational age (weeks) | 27 | 27 | 0.68 | 28 | 28 | 0.85 | 27 | 27 | 0.72 | 27 | 27 | 0.94 | 29 | 29 | 28.4 mean | |
| (25–29) | (25–29) | (26–27) | (26–27) | (25–29) | (25–29) | (25–29) | (25–29) | (27–30) | (27–30) | (2.3) | |||||||
| Birth weight (g) | 970 | 961 | 0.94 | 1040 | 1011 | 0.52 | 1006 | 925 | 0.95 | 908 | 910 | 0.93 | 1125.9 | 1143.3 | 1120 mean | ||
| (760–1188) | (716–1220) | (800–1260) | (864–1249) | (725–1168) | (692–1220) | (714–1160) | (697–1180) | 356.2 SD | 367.1 SD | (358) | |||||||
| Sample day of life (used in analysis) | 19 | 16 | 0.83 | 15 | 13 | 0.88 | 22 | 19 | 0.47 | 21 | 19 | 0.38 | – | – | – | ||
| (10–31) | (9–30) | (8–18) | (9–18) | (12–31) | (12–28) | (13–31) | (12–28) | – | – | – | |||||||
| First IMP exposure (day of life) | 5 | 5 | 0.53 | 4 | 5 | 0.5 | 5 | 5 | 0.79 | 5 | 5 | 0.8 | – | – | – | ||
| (4–7) | (4–6) | (4–6) | (4–7) | (3–7) | (4–7) | (4–7) | (4–8) | – | – | – | |||||||
| First feed (day of life) | 5 | 5 | 0.43 | 5 | 5 | 0.74 | 5 | 5 | 0.92 | 5 | 5 | 0.78 | – | – | – | ||
| (4–8) | (4–6) | (4–6) | (4–7) | (3–7) | (4–7) | (4–7) | (4–8) | – | – | – | |||||||
| Last parenteral nutrition (day of life) | 10 | 10 | 0.28 | 10 | 9 | 0.09 | 10 | 10 | 0.17 | 10 | 10 | 0.32 | – | – | – | ||
| (8–15) | (6–15) | (8–16) | (5–13) | (9–15) | (7–13) | (8–16) | (6–13) | – | – | – | |||||||
| Total count | Infants (samples) | 98 (620) | 103 (629) | – | 60 (154) | 58 (160) | – | 40 (82) | 43 (89) | – | 41 (100) | 49 (125) | – | 1098 | 1099 | Total count | 479 (33331) |
| No disease | 57 | 59 | 0.89 | 38 | 32 | 0.46 | 28 | 24 | 0.26 | 27 | 25 | 0.15 | – | – | – | ||
| Disease (NEC or LOS) | 41 | 44 | 0.4 | 22 | 26 | 0.46 | 12 | 19 | 0.27 | 14 | 24 | 0.68 | – | – | – | ||
| Confirmed NEC | 9 | 14 | 0.38 | 7 | 14 | 0.09 | 6 | 8 | 0.77 | 6 | 13 | 0.21 | 63 (6%) | 56 (5%) | 31 (6.5%) | ||
| Confirmed LOS | 32 | 30 | 0.65 | 20 | 16 | 0.56 | 10 | 11 | 1 | 14 | 15 | 0.82 | 190 (17%) | 180 (17%) | 81 (17%) | ||
| Multiple birth | 50 | 42 | 0.26 | 41 | 28 | 0.04 | 19 | 19 | 0.83 | 21 | 21 | 0.41 | 350 (32%) | 346 (31%) | 145 (30.2%) | ||
| Exclusively maternal milk fed | 54 | 56 | 0.88 | 31 | 30 | 1 | 19 | 24 | 0.51 | 21 | 30 | 0.5 | – | – | – | ||
| Exclusively formula fed | 9 | 11 | 0.82 | 7 | 9 | 0.7 | 2 | 4 | 0.68 | 2 | 4 | 0.83 | – | – | – | ||
| Mixed feeds | 35 | 37 | 1 | 23 | 19 | 0.6 | 19 | 15 | 0.27 | 19 | 16 | 0.28 | – | – | – | ||
IMP, Investigational Medicinal Product; LC-MS, liquid chromatography-mass spectrometry; LOS, late onset sepsis; NEC, necrotising enterocolitis; VOC, volatile organic compound.