Table 2. Primary and secondary outcomes.
| Outcome | Overall (n = 87) |
Poractant alfa (n = 42) |
Bovine lipid extract surfactant (n = 45) |
Odds Ratio (95% CI) |
Odds Ratio Adjusted for Site, GA, and Gender (95% CI) |
P Value |
|---|---|---|---|---|---|---|
| PRIMARY OUTCOME | ||||||
|
Alive and Extubated at 48h n(%) 24w0d – 26w6d GA 27w0d – 31w6d GA |
47 (54) n = 20 n = 27 |
21 (50) 12/26 (46.2) 9/16 (56.3) |
26 (57.8) 8/24 (33.3) 18/21 (85.71) |
0.74 (0.32–1.72) 1.67 (0.53–5.25) 0.24 (0.05–1.11) |
0.76 (0.30–1.93) 1.74 (0.53–5.73) 0.20 (0.04–1.09) |
0.56 0.37 0.06 |
| SECONDARY OUTCOMES | ||||||
| Surfactant doses received; n (%) | ||||||
| 1 | 70 (80.5) | 34 (81.0) | 36 (80.0) | 1.06 (0.37–3.01) | 1.04 (0.35–3.10) | 0.94* |
| 2 | 15 (17.2) | 8 (19.1) | 7 (15.6) | |||
| 3 | 2 (2.3) | 0 (0) | 2 (4.4) | |||
| Alive and Extubated at 1 week post-randomization; n (%) | 56 (64.4) | 29 (69.0) | 27 (60.0) | 1.47 (0.61–3.55) | 1.63 (0.61–4.37) | 0.33 |
| Successful first extubation; n (%)** | 46/83 (55.4) | 22/38 (57.9) | 24/45 (53.3) | 1.20 (0.50–2.86) | 1.16 (0.43–3.13) | 0.78 |
| BPD at 36w***; n (%) | 48/76 (63.2) | 17/33 (51.5) | 31/43(72.1) | 0.42 (0.16–1.09) | 0.35 (0.12–1.04) | 0.06 |
| Death; n (%) | 12 (13.8) | 9 (21.4) | 3 (6.7) | 3.44 (0.92–12.91) | 3.48 (0.94–12.88) | 0.06 |
| Death or BPD at 36w; n (%) | 59 (67.8) | 26 (61.9) | 33 (73.3) | 0.60 (0.24–1.48) | 0.52 (0.19–1.43) | 0.21 |
|
Hazard Ratio (95% CI) |
Hazard Ratio Adjusted for Site, GA, and Gender (95% CI) |
P Value | ||||
| Time to first extubation (days); median (IQR) | 1.00 (0.47, 3.23) | 1.05 (0.51, 2.61) | 0.83 (0.47, 5.04) | 1.29 (0.83–2.02) | 1.21 (0.76–1.94) | 0.43 |
| Total duration of respiratory support (days))**** | ||||||
| Mechanical ventilation; median (IQR) | 7.87 (1.06, 28.62) | 4.12 (1.49, 20.47) | 11.93 (0.83, 32.21) | 1.38 (0.84–2.27) | 1.17 (0.71–1.94) | 0.54 |
| Mechanical ventilation (survivors only); median (IQR) | 9.76 (1.03, 29.10); n = 75 | 6.18 (1.49, 22.46); n = 33 | 11.84 (0.83, 32.21); n = 42 | 1.12 (0.65–1.92) | 0.93 (0.52–1.64) | 0.79 |
| nCPAP; median (IQR) | 32 (13, 47) | 30.5 (11, 44) | 40 (21, 48) | 1.28 (0.78–2.08) | 1.38 (0.80–2.37) | 0.25 |
| nCPAP (survivors only); median (IQR) | 38 (24, 51); n = 75 | 36 (27, 51); n = 33 | 40 (24, 48); n = 42 | 1.03 (0.60–1.77) | 1.07 (0.58–1.97) | 0.83 |
| Duration of oxygen use; median (IQR) | 45 (27, 76) | 41.5 (20, 65) | 62 (38, 78) | 1.73 (1.06–2.83) | 1.69 (1.02–2.80) | 0.04 |
| Duration of oxygen use (survivors only) (n = 75); median (IQR) | 55 (36, 77); n = 75 | 51 (34, 65); n = 33 | 64 (38, 78); n = 42 | 1.44 (0.84–2.48) | 1.38 (0.78–2.45) | 0.27 |
* Comparing the group that received one surfactant dose vs. the group that received 2 or 3 doses
** Event of interest is not being reintubated within 1 week of first extubation. Patients who died during the first intubation period or within a week of the first extubation were excluded from the analysis.
*** One patient was diagnosed with BPD at 36 weeks and died on that day. This patient was included in the analysis for this outcome.
**** Total duration of respiratory support was calculated until death, discharge, or 36 weeks, whichever came first. Note that 16 patients were followed past 36 weeks until discharge, and for these patients, all available data were used to calculate total duration of respiratory support.