Table 3. Change From Baseline to Trial Completion in Developmental Outcomes.
| Outcome | DHA+AA/Placebo, No. at Baseline | Baseline Score, Mean (SD) | DHA+AA/Placebo, No. at End of Trial | Score at End of Trial, Mean (SD) | Change, Mean (SD) | Difference in Change (95% CI)a | ANCOVA Effect Size | P Value | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| DHA+AA | Placebo | DHA+AA | Placebo | DHA+AA | Placebo | ||||||
| Cognitive composite | 188/188b | 99.7 (13.9) | 101.3 (11.4) | 169/169 | 97.7 (11.8) | 97.7 (11.5) | −2.6 (13.3) | −3.7 (12.2) | 0.5 (−1.8 to 2.8) | 0.05 | .66 |
| Language composite | 187/188 | 92.5 (12.1) | 93.2 (12.1) | 169/169 | 92.5 (12.3) | 93.2 (13.2) | −0.5 (12.0) | 0.2 (12.6) | −0.7 (−3.1 to 1.6) | −0.07 | .55 |
| Motor composite | 187/188 | 96.1 (13.8) | 96.3 (11.1) | 168/169 | 96.3 (10.9) | 96.0 (12.5) | −0.6 (12.5) | −0.4 (12.7) | 0.2 (−2.1 to 2.4) | 0.02 | .88 |
| Effortful control | 188/185 | 5.3 (0.7) | 5.2 (0.8) | 160/163 | 4.6 (0.7) | 4.7 (0.8) | −0.7 (0.8) | −0.5 (0.8) | −0.1 (−0.3 to 0.0) | −0.16 | .13 |
| Activity level | 188/186 | 4.8 (1.2) | 4.9 (1.2) | 159/163 | 5.4 (1.1) | 5.4 (1.1) | 0.6 (1.5) | 0.5 (1.5) | 0.0 (−0.2 to 0.3) | 0.01 | .76 |
Abbreviations: AA, arachidonic acid; ANCOVA, analysis of covariance; DHA, docosahexaenoic acid.
a
Difference in Change column is based on a mixed-effects model (analogous to ANCOVA) using maximum likelihood to account for missing data (39 children did not participate in the last trial visit) and thus may differ from the results of the raw summary statistics presented for the within-group mean change and SD. Positive numbers indicate the effect tended to favor DHA even if not statistically significant.
b
One child’s baseline Bayley-III assessment was deemed invalid.