Table 2.
Outcome measures. Values are number affected/number in group (percentage) unless stated otherwise
| Outcomes | NIRS (n=86) | Blinded NIRS (control) (n=80) | Relative change in % (95% CI) | Adjusted relative risk (95% CI) | Adjusted P value (unadjusted) |
|---|---|---|---|---|---|
| Primary | |||||
| Median (interquartile range) burden of hypoxia and hyperoxia (%hours) | 36.1 (9.2-79.5) | 81.3 (38.5-181.3) (n=78) | −58 (−35 to −74) | NA | <0.001* |
| Secondary | |||||
| All cause mortality at term | 12/86 (14) | 20/80 (25) | NA | 0.50 (0.29 to 1.00) | 0.10 (0.049) |
| Brain injury on cerebral ultrasonography: | |||||
| None | 21/80 (26) | 26/77 (34) | NA | — | 0.11 (0.053) |
| Mild-moderate | 49/80 (61) | 33/77 (43) | NA | — | |
| Severe | 10/80 (13) | 18/77 (23) | NA | — | |
| Exploratory | |||||
| Median (interquartile range) burden of hypoxia (%hours) | 16.6 (5.4-68.1) | 53.6 (17.4-171.3) (n=78) | −58 (−24 to −76) | NA | 0.0012* |
| Mean (SD) burden of hyperoxia (%hours) | 1.2 (0.3-9.6) | 1.1 (0.1-23.4) (n=78) | 1 (−35 to 194) | NA | 0.98* |
| Necrotising enterocolitis† | 9/86 (11) | 10/80 (13) | NA | 0.83 (0.33 to 1.94) | 0.69 |
| Bronchopulmonary dysplasia‡ | 41/72 (57) | 28/60 (47) | NA | 1.27 (0.94 to 1.50) | 0.20 |
| Retinopathy of prematurity§ | 14/86 (16) | 8/80 (10) | NA | 1.64 (0.75 to 3.00) | 0.20 |
NA=not applicable.
*Data were log transformed to normalise distributions. P values originate from analysis with adjustment for gestational age category and trial site indicator and are adjusted for multiplicity. Medians and interquartile ranges are based on raw data obtained before transformation.
†Modified Bell’s stage 2 or 3.
‡Extra oxygen requirement at 36 weeks of gestation.
§Stage ≥3 on international classification.