Table 2

Cumulative risk of PSBI/clinically suspected sepsis

ProbioticsPlaceboCumulative risk ratiop Value*
NNCumulative riskNNCumulative risk
(%)95% CI(%)95% CIRR95% CI
(PSBI, by field investigator)
 All strata8466812.610.3 to 15.310767215.913.3 to 18.90.790.56 to 1.030.080
 1.5–1.99 kg4745.41.7 to 13.49147518.711.3 to 29.10.290.10 to 0.840.014
 2.0–2.49 kg8059413.511.0 to 16.59359715.612.9 to 18.70.860.66 to 1.140.303
 Male4832015.011.5 to 19.45432316.713.0 to 21.20.900.63 to 1.280.553
 Female3634810.37.5 to 14.05334915.211.8 to 19.40.680.46 to 0.990.056
Suspected sepsis (by physician)
 All strata386685.74.2 to 7.7546728.06.2 to 7.70.710.47 to 1.060.091
 1.5–1.99 kg†0740.00 to 5.987510.75.2 to 19.90.007
 2.0–2.49 kg385946.44.7 to 8.7465977.75.8 to 10.10.830.55 to 1.260.381
 Male213206.64.3 to 9.9303239.36.6 to 13.00.710.41 to 1.210.205
 Female173484.93.0 to 7.7243496.94.6 to 10.10.710.39 to 1.300.270
  • *p Values less than 0.05 have been shown in bold.

  • †RR and 95% CIs could not be calculated as no study subject in this group developed the outcome suspected sepsis (by physician).

  • PSBI, possible serious bacterial infection.