Table 3.
Adverse events (number of patients) and safety outcomes
| Standard group (n=308) | Modified group (n=307) | Mean difference (95% CI) | Odds ratio (95% CI) | p | Reduction in events per 1000 treated | ||
|---|---|---|---|---|---|---|---|
| Adverse events* | |||||||
| Any adverse event | 75 (24%) | 69 (22%) | .. | .. | .. | .. | |
| Respiratory adverse event | 49 (16%) | 50 (16%) | .. | .. | .. | .. | |
| Gastrointestinal adverse event | 7 (2%) | 12 (4%) | .. | .. | .. | .. | |
| Other adverse event | 27 (9%) | 14 (5%) | .. | .. | .. | .. | |
| Safety outcomes | |||||||
| Deaths | 2 (1%) | 0 | .. | .. | .. | .. | |
| Episodes of high dependency care | 8 (3%) | 13 (4%) | .. | .. | .. | .. | |
| Heart rate at discharge (bpm) | 133·8 (16·2)† | 135·0 (15·7)† | −1·16 (−3·70 to 1·37) | .. | 0·37 | .. | |
| Respiratory rate at discharge (breaths per min) | 38·0 (7·9) | 38·0 (6·4) | 0·09 (−1·05 to 1·23) | .. | 0·88 | .. | |
| Re-admission to hospital within 7 days (episodes; infants [%]) | 8 (6; 2%) | 5 (5; 2%) | .. | .. | .. | .. | |
| Re-admission to hospital within 28 days (episodes; infants [%]) | 26 (23; 7%) | 12 (12; 4%) | .. | .. | .. | .. | |
| Re-attendance health care within 7 days | 39/270 (14%) | 34/267 (13%) | .. | 0·98 (0·65 to 1·49) | 0·94 | 2 (−56 to 45) | |
| Re-attendance health care within 14 days | 76/267 (29%) | 70/258 (27%) | .. | 1·07 (0·73 to 1·57) | 0·73 | −14 (−88 to 79) | |
| Re-attendance health care after 28 days | 127/274 (46%) | 128/262 (49%) | .. | 0·90 (0·64 to 1·27) | 0·56 | 26 (−99 to 104) | |
| Antibiotics after discharge | 24/305 (8%) | 10/304 (3%) | .. | .. | .. | .. | |
Data are n (%), mean (SD), n/N (%), or difference (95% CI), unless otherwise specified. bpm=beats per min.
*
See appendix p 5 for more information about adverse events.
†
n=304.