TABLE 2.
Change from baseline to trial completion for growth and adiposity outcome measures in 10- to 16-mo-old (adjusted for prematurity) children born preterm (<35 wk gestation) randomized to receive either 180 d of DHA + AA (treatment) or corn oil (placebo), Omega Tots Trial (n = 377), 2012–20171
| DHA group | Placebo group | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Growth and adiposity outcomes | Baseline (n = 189) | Day 180 (n = 179) | Mean change | Baseline (n = 188) | Day 180 (n = 169) | Mean change | Difference in change2 | Effect size | P |
| Length, cm | 78.4 ± 3.4 | 84.5 ± 3.6 | 6.1 ± 2.5 | 77.6 ± 3.7 | 84.2 ± 3.6 | 6.6 ± 2.5 | −0.3 (−0.9, 0.2) | −0.14 | 0.20 |
| Length-for-age z score | 0.0 ± 1.2 | 0.1 ± 1.1 | 0.1 ± 0.9 | −0.2 ± 1.1 | 0.1 ± 1.0 | 0.2 ± 0.9 | −0.1 (−0.3, 0.1) | −0.11 | 0.27 |
| Weight, kg | 10.2 ± 1.0 | 11.5 ± 1.3 | 1.3 ± 0.7 | 10.1 ± 1.1 | 11.5 ± 1.3 | 1.3 ± 0.6 | 0.0 (−0.1, 0.2) | 0.03 | 0.80 |
| Weight-for-age z score | 0.1 ± 0.9 | 0.1 ± 0.9 | 0.1 ± 0.4 | 0.2 ± 0.8 | 0.2 ± 0.9 | 0.0 ± 0.4 | 0.0 (−0.1, 0.1) | 0.01 | 0.99 |
| Head circumference, cm | 46.9 ± 1.6 | 48.0 ± 1.6 | 1.0 ± 0.9 | 46.9 ± 1.8 | 48.0 ± 1.9 | 1.0 ± 0.7 | 0.1 (−0.1, 0.2) | 0.06 | 0.59 |
| Head circumference-for-age z score | 0.5 ± 1.0 | 0.5 ± 1.1 | −0.0 ± 0.6 | 0.6 ± 1.2 | 0.6 ± 1.3 | −0.1 ± 0.5 | 0.1 (−0.1, 0.2) | 0.09 | 0.39 |
| Mid-upper arm circumference, cm | 15.4 ± 1.1 | 15.7 ± 1.2 | 0.3 ± 0.9 | 15.4 ± 1.1 | 15.9 ± 1.2 | 0.4 ± 0.9 | −0.1 (−0.3, 0.1) | −0.12 | 0.25 |
| Mid-upper arm circumference z score | 0.7 ± 0.9 | 0.7 ± 0.9 | 0.0 ± 0.8 | 0.7 ± 0.9 | 0.8 ± 0.9 | 0.1 ± 0.7 | −0.1 (−0.3, 0.1) | −0.12 | 0.25 |
| Triceps skinfold, mm | 10.7 ± 1.9 | 10.4 ± 2.0 | −0.2 ± 1.5 | 11.1 ± 2.2 | 10.9 ± 2.3 | −0.3 ± 1.9 | 0.0 (−0.3, 0.4) | 0.02 | 0.86 |
| Triceps skinfold-for-age z score | 1.4 ± 0.8 | 1.4 ± 0.9 | −0.0 ± 0.7 | 1.6 ± 1.0 | 1.5 ± 1.0 | −0.1 ± 0.8 | 0.0 (−0.1, 0.2) | 0.02 | 0.85 |
| Subscapular skinfold, mm | 6.9 ± 1.7 | 6.6 ± 2.1 | −0.2 ± 1.7 | 7.2 ± 1.7 | 6.7 ± 1.6 | −0.5 ± 1.4 | 0.2 (−0.2, 0.5) | 0.10 | 0.34 |
| Subscapular skinfold-for-age z score | 0.3 ± 1.2 | 0.1 ± 1.3 | −0.2 ± 0.8 | 0.5 ± 1.2 | 0.3 ± 1.2 | −0.2 ± 0.9 | −0.0 (−0.2, 0.2) | −0.02 | 0.82 |
| BMI, percentile | 16.6 ± 1.6 | 16.1 ± 1.6 | −0.5 ± 1.3 | 16.8 ± 1.3 | 16.2 ± 1.4 | −0.7 ± 1.1 | 0.1 (−0.2, 0.3) | 0.08 | 0.43 |
| BMI-for-age z score | 0.2 ± 1.1 | 0.2 ± 1.2 | −0.0 ± 0.9 | 0.4 ± 0.9 | 0.3 ± 1.0 | −0.1 ± 0.8 | 0.1 (−0.1, 0.2) | 0.07 | 0.53 |
| Weight-for-length z score | 0.2 ± 1.0 | 0.1 ± 1.1 | 0.0 ± 0.9 | 0.3 ± 0.9 | 0.2 ± 1.0 | −0.1 ± 0.7 | 0.1 (−0.1, 0.2) | 0.10 | 0.36 |
| Body fat percentage | 16.9 ± 2.8 | 16.4 ± 3.0 | −0.4 ± 2.0 | 17.5 ± 3.0 | 16.8 ± 2.9 | −0.7 ± 2.3 | 0.2 (−0.3, 0.6) | 0.08 | 0.46 |
1
Values are means ± SDs, frequencies, difference in change (95% CIs), Cohen's d effect sizes, and P values.
2
Difference in change column is based on a mixed-effects model that uses maximum likelihood to account for missing data.