Intention to treat analysis for clinical outcomes (N=35)
| Clinical outcomes | Surfactant nebulisation (N=18) | Standard care (N=17) | P value | Padj value |
| In the delivery room | ||||
| Number of face mask repositionings | 2 (1 to 3) | 2 (1 to 2) | 0.73 | 1 |
| Episodes of hypothermia or hyperthermia | 0 (0 to 1) | 0 (0 to 1) | 0.92 | 1 |
| First blood gas analysis infant* | ||||
| pH | 7.18 (7.16 to 7.21) | 7.19 (7.16 to 7.25) | 0.37 | 1 |
| pCO2 (kPa) | 8.6 (6.9 to 9.2) | 7.2 (7.1 to 8.9) | 0.74 | 1 |
| Base excess (mmol/L) | −5.1 (−7.4 to −3.0) | −4.2 (−5.9 to −3.3) | 0.59 | 1 |
| Lactate (mmol/L) | 2.9 (2.4 to 5.4) | 3.6 (2.8 to 5.2) | 0.61 | 1 |
| In the first 24 hours after birth | ||||
| Time of admission to NICU (min) | 46 (36 to 51) | 36 (31 to 49) | 0.12 | 1 |
| Temperature at admission (°C) | 37 (37 to 37.2) | 37.1 (36.7 to 37.3) | 0.84 | 1 |
| Episodes of desaturation† | 0 (0 to 2) | 0 (0 to 1) | 0.85 | 1 |
| Episodes of bradycardia† | 0 (0 to 0) | 0 (0 to 0) | 0.52 | 1 |
| During hospital stay | ||||
| Respiratory failure, n (%) | 8/18 (44) | 5/17 (29) | 0.57 | 1 |
| MIST, n (%) | 4/18 (22) | 1/17 (6) | 0.37 | 1 |
| Mechanical ventilation, n (%) | 4/18 (22) | 4/17 (24) | 1 | 1 |
| Time to respiratory failure (hours) | 3 (1 to 21) | 16 (8 to 29) | 0.62 | 1 |
| Doses of surfactant‡ | 1 (1 to 2) | 0 (0 to 0) | <0.001 | <0.001 |
| Time on respiratory support (days) | 29 (7 to 44) | 28 (5 to 58) | 0.78 | 1 |
| Mechanical ventilation | 0 (0 to 0) | 0 (0 to 0) | 0.86 | 1 |
| NIPPV | 0 (0 to 1) | 0 (0 to 2) | 0.66 | 1 |
| CPAP | 9 (5 to 26) | 22 (5 to 44) | 0.36 | 1 |
| High flow | 8 (0 to 23) | 8 (0 to 12) | 0.71 | 1 |
| BPD, n (%) | 1 (6) | 1 (6) | 1 | 1 |
| Air leak, n (%) | 2 (11) | 2 (12) | 1 | 1 |
| Pneumothorax | 1 (5) | 1 (6) | ||
| PIE | 1 (5) | 1 (6) | ||
| Pulmonary haemorrhage, n (%) | 0 (0) | 0 (0) | 1 | 1 |
| Surgical closure of PDA, n (%) | 0 (0) | 1 (6) | 0.98 | 1 |
| IVH≥grade 2, n (%) | 0 (0) | 0 (0) | 1 | 1 |
| Any grade ROP, n (%) | 2 (11) | 0 (0) | 0.49 | 1 |
| Surgically treated NEC, n (%) | 0 (0) | 0 (0) | 1 | 1 |
| Blood culture-positive sepsis, n (%) | 0 (0) | 2 (12) | 0.44 | 1 |
| Length of hospital stay (days) | 48 (37 to 65) | 48 (44 to 76) | 0.32 | 1 |
| Post-menstrual age at discharge | 37 (35.8 to 38) | 36.9 (35.7 to 39.3) | 0.57 | 1 |
| Mortality, n (%) | 0 (0) | 0 (0) | 1 | 1 |
*Blood gas analysis was drawn at approximately 15 min after birth, corresponding to immediately after nebulisation in the intervention group.
† Episodes of desaturation or bradycardia were based on a score for apnea of prematurity as previously described.41
‡Any dose >100 mg/kg, irrespective of mode of administration (ie, intratracheal or nebulised).
BPD, bronchopulmonary dysplasia; CPAP, continuous positive airway pressure support; IVH, intraventricular haemorrhage; MIST, minimally invasive surfactant application; NEC, necrotising enterocolitis; NICU, neonatal intensive care unit; NIPPV, non-invasive intermittent positive pressure ventilation; Padj, adjusted p value using the Bonferroni-Holm method; PDA, patent ductus arteriosus; PIE, pulmonary interstitial emphysema; ROP, retinopathy of prematurity.