Weaning and secondary outcomes
| nHF (n=59) | nCPAP (n=61) | OR (95% CI) or median difference and 95% CI* | |
| Postmenstrual age at first trial off respiratory support, weeks | 31 (30–32) | 31 (30–33) | 0 (–1 to 0)* |
| Treatment failure occurring during 72 hours off respiratory support† | 14 (24.1) | 29 (47.5) | 0.49 (0.24 to 1.03) |
| Requirement for increase flow/pressure† | 31 (52.5) | 21 (34.4) | 1.53 (0.78 to 2.95) |
| Requirement for rescue to CPAP>6 cm water† | 13 (22.4) | 12 (19.7) | 1.12 (0.47 to 2.65) |
| Total number of infants who had any treatment failures | 35 (59.3) | 35 (57.4) | 1.03 (0.57 to 1.86) |
| Escalation for† | |||
| Six desaturations/bradycardias in 6 hours | 23 (65.7) | 23 (65.7) | 1.03 (0.52 to 2.04) |
| Tachypnoea | 22 (62.8) | 21 (60) | 1.08 (0.54 to 2.17) |
| Increase oxygen >0.30 | 5 (14.2) | 4 (11.4) | 1.29 (0.33 to 5.05) |
| Intermittent positive pressure ventilation | 1 (2) | 1 (2) | 1.03 (0.06 to 16.9) |
| Other‡ | 3 (8.6) | 0 (0) | 3.1 (0.31 to 30.67) |
| Postmenstrual age at completed primary outcome, weeks | 33 (31–35) | 33 (31–35) | 0 (–0.7 to 0.8)* |
| Did not complete primary outcome of 72 hours off respiratory support by 36 weeks’ PMA | 6 (10.2) | 12 (19.7) | 0.51 (0.18 to 1.46) |
| Time to first suck feed, restricted mean days§ | 38.6 | 39.1 | 0.63¶ |
| Time to full suck feed, restricted mean days§ | 65 | 66.2 | 0.35¶ |
| Discharged home exclusive breast feeding | 12 (21) | 13 (22) | 0.95 (0.40 to 2.26) |
| Discharged home with feeding tube | 13 (22) | 12 (20) | 1.12 (0.47 to 2.65) |
| Z-score change in weight (randomisation to discharge) | 0.18 (±0.60) | 0.22 (±0.79) | 0.19 (0.41 to −0.02)**†† |
| Age at discharge, days | 79 (63–86) | 78.5 (69–98) | 4 (-5 to 11)* |
| Necrotising enterocolitis | 0 (0) | 2 (3) | 0.97 (0.92 to 1.01) |
| Chronic lung disease†† | 11 (18) | 22 (36) | 0.42 (0.18 to 0.99) |
| Late-onset sepsis | 6 (10) | 8 (13) | 0.77 (0.25 to 2.37) |
| Retinopathy of prematurity: stage 3 | 1 (1.7) | 3 (5) | 0.34 (0.03 to 3.4) |
| Intraventricular haemorrhage: grade 3/4 | 1 (1.7) | 0 (0) | 1.02 (0.98 to 1.05) |
| Nasal trauma | 2 (3) | 4 (6) | 0.51 (0.09 to 2.9) |
| Discharged home on low flow oxygen | 6 (10.2) | 5 (8.2) | 1.24 (0.5 to 4.28) |
Data are shown as median (IQR) or number (%) unless stated otherwise.
†Infants could meet failure criteria more than once during the primary outcome period (randomisation—72 hours off respiratory support) and could fail due to more than one reason.
‡Decision made at doctors’ discretion outside of protocol.
§Corrected for hours on respiratory support and gestation at birth.
¶P value.
**Z-score change.
††Corrected for sibling factor and gestation at birth.
nCPAP, nasal continuous positive airway pressure; nHF, high flow nasal cannula; PMA, postmenstrual age.