Table 2 Results of the study of efficacy and safety of EcN for immunity improvement in late preterm newborns
After 28 days of life | After 6 months of life | After 12 months of life | ||||
|---|---|---|---|---|---|---|
EcN (N = 30) | Control (N = 32) | EcN (N = 30) | Control (N = 32) | EcN (N = 30) | Control (N = 32) | |
Efficacy measures | ||||||
Total number and % of participants with at least 1 ARI | 3 (10.0) | 14 (43.7) | 15 (50.0) | 23 (71.9) | 23 (76.7) | 30 (93.8) |
Χ2cor. = 7.25; p = 0.008 | Χ2cor. = 2.27; p = 0.132 | Χ2cor. = 1.32; p = 0.251 | ||||
Mean number of ARI events | 0.10 − 0.01–0.21 | 0.44 0.26–0.61 | 0.50 0.31–0.68 | 0.94 0.69–1.19 | 0.90 0.68–1.12 | 1.31 1.08–1.54 |
z = 2.28, p = 0.02 | z = 2.21, p = 0.03 | z = 2.11, p = 0.03 | ||||
Mean number of hospitalizations due to ARIs | 0.03 − 0.03–0.01 | 0.34 0.18–0.51 | 0.13 0.01–0.26 | 0.53 0.33–0.73 | 0.27 0.11–0.43 | 0.56 0.37–0.76 |
z = 2.01, p = 0.04 | z = 2.50, p = 0.01 | z = 1.84, p = 0.07 | ||||
Mean duration of hospitalizations due to ARIs (days) | 0.27 − 0.26–0.79 | 2.16 0.98–3.34 | 1.20 0.03–2.37 | 4.06 2.48–5.64 | 2.43 0.86–4.01 | 4.21 2.66–5.78 |
z = 1.85, p = 0.06 | z = 2.40, p = 0.02 | z = 1.59, p = 0.11 | ||||
RR | 0.23 | 0.70 | 0.82 | |||
RRR | 0.77 | 0.30 | 0.18 | |||
NNT | 3 | 5 | 6 | |||
Safety measures | ||||||
Total number of AEs | 0 | 6 | 23 | 21 | 28 | 30 |
Total number of drug- related AEs | 0 | 0 | 0 | 0 | 0 | 0 |
Mean body weight (g) | N/A | N/A | 6623 ± 268 | 6419 ± 164 | 9765 ± 446 | 9634 ± 532 |
Mean body length (cm) | N/A | N/A | 61.4 ± 1.1 | 61.2 ± 0.9 | 73.0 ± 1.2 | 73.3 ± 1.4 |