TABLE 7.
Adverse events | Overall | Site 1 | Site 2 | Site 3 | Site 4 | p‐Value |
---|---|---|---|---|---|---|
Apnea a | 0.2 (0.6) | 0.2 (0.5) | 0.1 (0.4) | 0.7 (1.3) | 0.1 (0.4) | 0.002 |
Bradycardia a | 0.5 (1.1) | 0.8 (1.4) | 0.2 (0.8) | 0.7 (1.1) | 0.4 (0.7) | 0.024 |
Choking/Gagging a | 0.5 (1.2) | 0.8 (1.3) | 0.2 (0.7) | 1.00 (2.0) | 0.2 (0.7) | 0.007 |
Tachycardia a | 2.6 (4.8) | 2.2 (4.6) | 2.0 (4.7) | 5.0 (6.2) | 2.5 (3.5) | 0.079 |
O2 Desaturation a | 4.2 (8.4) | 5.3 (7.7) | 3.0 (7.6) | 7.2 (12.3) | 2.2 (6.3) | 0.091 |
Total/infant a | 7.9 (12.7) | 9.3 (11.8) | 5.6 (11.2) | 14.5 (19.2) | 5.5 (8.0) | 0.017 |
Values expressed as mean and standard deviation (SD) per infant.