Table 3.

Primary composite outcome measure, primary outcome measures, and secondary outcome variables at term age or before discharge, adjusted for trial site

Outcome measures and variables	Near infrared spectroscopy group (n=304)	Control group (n=303)	Relative risk (95% CI)	P value
Primary composite outcome
Survival without cerebral injury*	252 (82.9)	238 (78.5)	1.06 (0.98 to 1.14)
Primary outcome measures
Death or cerebral injury, or both*	52 (17.1)	65 (21.5)	0.80 (0.57 to 1.11)
Death	12 (4.0)	16 (5.3)	0.75 (0.33 to 1.70)
Intraventricular haemorrhage:
Any grade	41 (13.5)	55 (18.2)	0.74 (0.52 to 1.06)
Absent	263 (86.5)	248 (81.9)		0.29
Grade I-II	29 (9.5)	39 (12.9)
Grade III-IV	12 (4.0)	16 (5.3)
Cystic periventricular leukomalacia:
Any grade	8 (2.6)	3 (1.0)	2.66 (0.80 to 8.80)
Absent	296 (97.4)	300 (99.0)		0.24
Grade II	3 (1.0)	2 (0.7)
Grade III	5 (1.6)	1 (0.3)
Secondary outcome measures (morbidities)
Respiratory distress syndrome:
Present	248 (81.6)	244 (80.5)	1.01 (0.96 to 1.07)
Absent	56 (18.4)	59 (19.5)		0.92
Not defined	26 (8.6)	28 (9.2)
Grade 1-2	163 (53.6)	163 (53.8)
Grade 3-4	59 (19.4)	53 (17.5)
Culture proven sepsis	91 (29.9)	111 (36.6)	0.82 (0.67 to 1.00)
Necrotising enterocolitis any grade	17 (5.6)	15 (5.0)	1.13 (0.57 to 2.24)
Bronchopulmonary dysplasia†	54 (17.8)	57 (18.8)	0.94 (0.67 to 1.34)
Retinopathy of prematurity ≥grade 2	35 (11.5)	33 (10.9)	1.06 (0.68 to 1.65)
Persistent ductus arteriosus with intervention‡	41 (13.5)	54 (17.8)	0.76 (0.57 to 1.01)

CI=confidence interval.

^*Any intraventricular haemorrhage or cystic periventricular leukomalacia, or both, at term age or before discharge.

^†Oxygen dependency or need for respiratory support at 36 weeks corrected age.

^‡Medical intervention or surgical intervention, or both.