Table 4.
Results from the IMpact Study, a Randomized Placebo Controlled Trial on Palivizumab in Preterm Children with and Without Bronchopulmonary Dysplasia [45]
| RSV Hospitalization | Palivizumabn = 1002 | Placebon = 500 | Relative Reduction (%) | p-Value* |
|---|---|---|---|---|
| Preterm infants ≤ 35 weeks (including BPD) | 4.8 % | 10.6 % | 55% | <0.001 |
| Preterm infants ≤ 35 weeks (no BPD) | 1.8 % | 8.1 % | 78% | <0.001 |
| all BPD | 7.9 % | 12.8 % | 39% | 0.038 |
| Preterm infants 32-35 weeks (no BPD) | 1.8 % | 10.0 % | 82% | <0.001 |
| Total days hospitalization/ 100 children | 36.4 | 62.6 | - | <0.001 |
| Total days with supplemental oxygen | 30.3 | 50.6 | - | <0.001 |
| Total days with LRI-score ≥ 3 | 29.6 | 47.4 | - | <0.001 |
| ICU admission | 1.3 % | 3% | - | 0.026 |
| Total ICU days | 12.7 | 13.3 | - | 0.023 |
| Mechanical ventilation | 0.2 % | 0.7 % | - | 0.280 |
| Total days of mechanical ventilation | 1.7 | 8.4 | - | 0.210 |
BPD = bronchopulmonary dysplasia, LRI-score = lower respiratory tract infection score (0 = no illness, 5 = mechanical ventilation), ICU = intensive care unit
*
Fisher´s exact test