Table 1.
RSV-IGIV (n = 250) | Placebo (n = 260) | Reduction | P value | |
---|---|---|---|---|
Incidence of RSVH (%) | 8.0 | 13.5 | 41% | 0.047 |
Total days of hospitalization per 100 children | 60 | 129 | 53% | 0.045 |
Total days of RSVH requiring increased supplemental oxygen per 100 children | 34 | 85 | 60% | 0.007 |
Number of hospital days with moderate or severe LRI (LRI score ≥ 3a) per 100 children | 49 | 106 | 54% | 0.049 |
Total days of ICU or mechanical ventilation for RSV per 100 children | 28 | 50 | – | – |
ICU intensive care unit, LRI lower respiratory infection/illness, RSV-IGIV respiratory syncytial virus intravenous immunoglobulin, RSVH respiratory syncytial virus hospitalization
aLRI score: 0 = no respiratory illness/infection; 1 = upper respiratory tract illness (URI); 2 = mild LRI; 3 = moderate LRI; 4 = severe LRI; 5 = mechanical ventilation. The LRI score was calculated as the mode of the following three (A, B, C) component scores, or the mean if there was no mode: A. Oxygen saturation—0 = Baseline value (no URI), 1 = Baseline value (URI), 2 = Decrease < 5%, 3 = Decrease 5–10%, 4 = Decrease > 10%, 5 = Mechanical ventilation; B. Respiratory rate—0 = Baseline value (no URI), 1 = Baseline value (URI), 2 = Increase 1–14/min, 3 = Increase 15-30/min, 4 = Increase > 30/min, 5 = Mechanical ventilation; C. Retractions, Wheezing, Crackles—0 = No change (no URI), 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Mechanical ventilation [51]. Values for oxygen saturation, respiratory rate, and pulmonary findings were compared with baseline values on usual oxygen flow [51]