Primary and secondary outcomes
| Intention-to-treat analysis | As-treated analysis | ||||||||
| N* | HF (n=55) | LF (n=52) | Mean difference (95% CI)† or GMR (95% CI)¶ | P value‡ | HF (n=55) | LF (n=52) | Mean difference (95% CI)† or GMR (95% CI)¶ | P value‡ | |
| Decrease in VWS ≥2 points (hours) | |||||||||
| 2 | 94* | 25/45 (55.6) | 24/49 (49.0) | 6.6 (–13.6 to 26.8) | 0.52 | 26/46 (47.9) | 23/48 (56.5) | −8.6 (–18.8 to 1.6) | 0.40 |
| 6 | 95* | 24/46 (52.2) | 31/49 (63.3) | −11.1 (–30.9 to 8.7) | 0.27 | 25/47 (53.2) | 30/48 (62.5) | −9.3 (–29.1 to 10.5) | 0.36 |
| 12 | 97* | 35/47 (74.5) | 31/50 (62.0) | 12.5 (–1.5 to 26.5) | 0.18 | 38/48 (75.0) | 30/49 (61.2) | 13.8 (–4.5 to 32.1) | 0.15 |
| 24 | 99* | 35/48 (72.9) | 40/51 (78.4) | −5.5 (–23.5 to 12.6)‡ | 0.52 | 35/50 (70.0) | 40/49 (81.6) | −11.6 (–29.0 to 6.7)‡ | 0.18 |
| VWS (hours), mean (SD) | |||||||||
| 2 | 94* | 5.2 (2.3) | 5.5 (2.1) | −0.3 (–1.2 to 0.6) | 0.55 | 5.2 (2.3) | 5.6 (2.0) | −0.4 (–1.3 to 0.5) | 0.36 |
| 6 | 95* | 5.6 (2.3) | 4.7 (1.5) | −0.9 (–1.7 to –0.1) | 0.03 | 5.5 (2.3) | 4.8 (1.5) | −0.8 (–1.6 to 0.1) | 0.06 |
| 12 | 97* | 5.1 (2.3) | 4.8 (1.7) | −0.3 (–1.1 to 0.6) | 0.52 | 5.0 (2.3) | 4.9 (1.7) | −0,1 (–1.0 to 0.6) | 0.73 |
| 24 | 99* | 4.0 (1.3) | 4.2 (1.9) | −0.2 (–0.9 to 0.5) | 0.53 | 3.9 (1.3) | 4.2 (1.8) | −0.3 (–1.0 to 0.4) | 0.37 |
| VWS ≥8 (hours) | |||||||||
| 2 | 94* | 10/45 (22.2) | 9/49 (18.4) | 3.8 (–12.5 to 20.1) | 0.64 | 10/46 (21.7) | 9/48 (18.8) | −13.4 (–29.7 to 2.9) | 0.72 |
| 6 | 95* | 8/46 (17.4) | 1/49 (2.0) | 15.4 (5.6 to 25.2) | 0.01 | 8/47 (17.0) | 1/48 (2.1) | 14.9 (3.4 to 26.4) | 0.01 |
| 12 | 97* | 8/47 (17.0) | 5/50 (10.0) | 7.0 (–6.6 to 20.6) | 0.31 | 8/48 (16.7) | 5/49 (10.2) | 6.5 (–7.0 to 20.0) | 0.35 |
| 24 | 99* | 1/41 (2.4) | 2/48 (4.2) | −1.8 (–9.2 to 5.6) | 0.65 | 1/42 (2.4) | 2/47 (4.3) | −1.9 (–9.3 to 5.5) | 0.63 |
| FLACC (hours), median (IQR) | |||||||||
| 2 | 78* | 1 (0–3) | 1 (0–3) | Not applicable | 0.50 | 1 (0–3) | 1 (0–3) | Not applicable | 0.36 |
| 6 | 73* | 1 (0–3) | 1 (0–3) | Not applicable | 0.95 | 1 (0–3) | 1 (0–3) | Not applicable | 0.95 |
| 12 | 75* | 0 (0–2) | 1 (0–3) | Not applicable | 0.17 | 0 (0–2) | 1.5 (0–3) | Not applicable | 0.11 |
| 24 | 73* | 0 (0–0.5) | 1 (0–2) | Not applicable | 0.03 | 0 (0–1) | 1 (0–2) | Not applicable | 0.05 |
| Length of stay (days), median (IQR) | 107 | 4.2 (3.7–6.4) | 4.8 (2.9–7.9) | 0.96 (0.8 to 1.3)¶ | 0.78 | 4.7 (3.7–6.4) | 4.3 (2.9–7.9) | 1.0 (0.8 to 1.3)¶ | 0.98 |
| Oxygen supplementation (days), median (IQR) | 103* | 3.3 (2.3–4.9) | 2.9 (2.0–5.2) | 1.9 (0.7 to 1.3)¶ | 0.72 | 2.9 (1.9–4.3) | 2.6 (1.9–5.0) | 1.1 (0.8 to 1.6)¶ | 0.43 |
| Intensive care§ | 107 | 8/55 (14.5) | 6/52 (11.5) | 3.0 (–11.7 to 17.4)† | 0.78 | 9/55 (16.4) | 5/52 (9.6) | 6.7 (–7.9 to 21.0)† | 0.39 |
| Tube feeding | 105* | 41/53 (77.4) | 38/52 (73.1) | 4.3 (–13.4 to 21.7)† | 0.61 | 42/54 (77.8) | 37/51 (72.5) | 5.2 (–12.4 to 22.7)† | 0.54 |
N (%) unless otherwise stated.
VWS 0–24.
FLACC non-normal distribution, 0-10.
*Lower than 107 due to missing data.
†95% CI.
‡Independent t-test for normally distributed variables, Mann-Whitney U test for non-normally distributed variables and χ2 for dichotomous variables.
§All patients transferred to the paediatric intensive care unit underwent invasive mechanical ventilation.
¶GMR.
FLACC, face, legs, activity, cry, consolability; GMR, geometric mean ratio; HF, high flow; LF, low flow; VWS, Vital Warning Score.