Table 2.
Neonatal Respiratory Outcomes
| Outcome | Betamethasone (N=1427) | Placebo (N=1400) | Relative Risk (95% CI) | P Value |
|---|---|---|---|---|
| Primary outcome* | 165 (11.6) | 202 (14.4) | 0.80 (0.66-0.97) | 0.02 |
| CPAP/HFNC for ≥ 2 continuous hours | 145 (10.2) | 184 (13.1) | 0.77 (0.63-0.95) | 0.01 |
| FiO2 ≥30% for ≥ 24 continuous hours | 48 (3.4) | 61 (4.4) | 0.77 (0.53-1.12) | 0.17 |
| Mechanical ventilation | 34 (2.4) | 43 (3.1) | 0.78 (0.50-1.21) | 0.26 |
| ECMO | 0 (0.0) | 0 (0.0) | - | N/A |
| Stillbirth or neonatal death < 72 hours | 0 (0.0) | 0 (0.0) | - | N/A |
| Severe respiratory morbidity** | 115 (8.1) | 169 (12.1) | 0.67 (0.53-0.84) | < 0.001 |
| CPAP/HFNC for ≥ 12 continuous hours | 93 (6.5) | 147 (10.5) | 0.62 (0.48-0.80) | <0.001 |
| FiO2 ≥30% for ≥ 24 continuous hours | 20 (1.4) | 34 (2.4) | 0.58 (0.33-1.00) | 0.05 |
| Respiratory distress syndrome | 79 (5.5) | 89 (6.4) | 0.87 (0.65-1.17) | 0.36 |
| Transient tachypnea of the newborn | 95 (6.7) | 138 (9.9) | 0.67 (0.53-0.87) | <0.01 |
| Apnea | 33 (2.3) | 37 (2.6) | 0.88 (0.55-1.39) | 0.57 |
| Bronchopulmonary dysplasia | 2 (0.1) | 9 (0.6) | 0.22 (0.02-0.92)# | 0.04 |
| Surfactant use | 26 (1.8) | 43 (3.1) | 0.59 (0.37-0.96) | 0.03 |
| Need for immediate resuscitation | 206(14.5) | 260 (18.7) | 0.78(0.66-0.92) | 0.003 |
Data expressed as N (%)
CPAP – continuous positive airway pressure
HFNC – high flow nasal cannula
*
Primary outcome is defined as any of the following in the first 72 hours: continuous positive airway pressure (CPAP) or high flow nasal cannula (HFNC) for ≥ 2 continuous hours; oxygen requirement with FiO2 of ≥30% for ≥4 continuous hours; mechanical ventilation; neonatal death; or stillbirth or need for ECMO
**
Severe respiratory morbidity is defined as any of the following in the first 72 hours: CPAP or HFNC for ≥ 12 hours; oxygen requirement with FIO2 ≥ 30% for ≥24 hours, mechanical ventilation, neonatal death; or stillbirth or need for ECMO.
#
Exact confidence limits19.