Table 2

Primary, secondary, adjusted and post-hoc analyses

Randomised group: AA:DHA (n=84)Randomised group: control (n=93)P valueUnadjusted difference between groups:
mean (95% CI)
Adjusted P value*
Primary analysis: full analysis set
Maximum ROP-ActS4.0 (4.9)
2 (0; 14)
(2.9; 5.0)
5.3 (5.6)
3 (0; 18)
(4.1; 6.4)
0.11−1.29 (−2.87 to 0.26)0.057
Maximum mROP-ActS4.2 (4.9)
2 (0; 14)
(3.1; 5.3)
5.4 (5.5)
5 (0; 18)
(4.2; 6.5)
0.14−1.16 (−2.72 to 0.37)0.087
Secondary analyses: full analysis set
Severe ROP (stage 3 and type 1)
 No67 (79.8%)59 (63.4%)16.3 (2.2 to 30.5)
 Yes17 (20.2%)34 (36.6%)0.025−16.3 (−30.5 to −2.2)0.0072
Maximum ROP stage
 No ROP35 (41.7%)37 (39.8%)1.9 (−13.8 to 17.5)
 Stage 115 (17.9%)7 (7.5%)10.3 (−0.6 to 21.3)
 Stage 217 (20.2%)16 (17.2%)3.0 (−9.6 to 15.7)
 Stage 317 (20.2%)33 (35.5%)0.12−15.3 (−29.4 to −1.1)0.057
Most central zone (grouped)
 No ROP35 (41.7%)37 (39.8%)1.9 (−13.8 to 17.5)
 III11 (13.1%)7 (7.5%)5.6 (−4.6 to 15.7)
 I or II38 (45.2%)49 (52.7%)0.51−7.5 (−23.3 to 8.4)0.48
Plus disease
 No72 (85.7%)72 (77.4%)8.3 (−4.2 to 20.8)
 Yes12 (14.3%)21 (22.6%)0.22−8.3 (-20.8 to 4.2)0.10
Post-hoc analyses: infants with any ROP in the full analysis set
Maximum ROP-ActS6.8 (4.7)
7 (1; 14)
(5.4; 8.2)
8.7 (4.6)
8 (1; 18)
(7.5; 10.0)
0.039−1.94 (−3.75 to 0.12)0.024
Maximum mROP-ActS7.2 (4.5)
7 (1; 14)
(5.9; 8.5)
8.9 (4.4)
8 (1; 18)
(7.7; 10.1)
0.055−1.71 (-−3.43 to 0.03)0.038
Severe ROP
 No32 (65.3%)22 (39.3%)26.0 (5.6 to 46.4)
 Yes17 (34.7%)34 (60.7%)0.013−26.0 (-46.4 to −5.6)0.0057
Maximum ROP stage
 Stage 115 (30.6%)7 (12.5%)18.1 (0.7 to 35.6)
 Stage 217 (34.7%)16 (28.6%)6.1 (−13.6 to 25.9)
 Stage 317 (34.7%)33 (58.9%)0.0060−24.2 (−44.7 to −3.8)0.0031
Most central zone (grouped)
 III11 (22.4%)7 (12.5%)0.289.9 (−6.5 to 26.4)0.19
 I or II38 (77.6%)49 (87.5%)−9.9 (−26.4 to 6.5)
Plus disease
 No37 (75.5%)35 (62.5%)13.0 (−6.4 to 32.4)
 Yes12 (24.5%)21 (37.5%)0.22−13.0 (−32.4 to 6.4)0.11
  • For continuous variables, mean (SD)/median (minimum; maximum)/(95% CI for mean using the inversion of Fisher’s non-parametric permutation test)/n=is presented.

  • *Adjusting for GA (weeks) and centre using multivariable linear regression handling AA:DHA intervenion group as the main effect variable, and ROP-ActS, mROP-ActS, ROP stage and zone as dependent variables in separate analyses. For severe ROP and plus disease as outcome (dependent variable), multivariable logistic regression was used instead.

  • AA, arachidonic acid; DHA, docosahexaenoic acid; GA, gestational age; mROP-ActS, modified Retinopathy of Prematurity Activity Scale; ROP, retinopathy of prematurity; ROP-ActS, Retinopathy of Prematurity Activity Scale.