TABLE 3.
Primary and secondary outcomes1
| Placebo(n = 147) | DHA(n = 154) | P value2 | |
| Primary outcomes | |||
| RBC-phospholipid-DHA (% by wt)3 | |||
| All (n = 301)4 | 4.7 ± 1.3 | 7.3 ± 2.2 | <0.001 |
| Not black (n = 184) | 4.8 ± 1.3 | 7.8 ± 2.1 | |
| Black (n = 117) | 4.7 ± 1.3 | 6.2 ± 2.0 | |
| Gestational age (d) | |||
| All | 272.8 ± 17.0 | 275.7 ± 11.2 | 0.041 |
| Not black | 273.8 ± 14.0 | 275.9 ± 9.9 | |
| Black | 271.4 ± 20.3 | 275.2 ± 13.3 | |
| Birth weight (g) | |||
| All | 3187 ± 602 | 3359 ± 524 | 0.004 |
| Not black | 3282 ± 529 | 3489 ± 456 | |
| Black | 3060 ± 671 | 3110 ± 559 | |
| Birth length (cm) | |||
| All | 49.0 ± 3.4 | 49.7 ± 2.7 | 0.022 |
| Not black | 49.2 ± 2.9 | 50.0 ± 2.6 | |
| Black | 48.6 ± 4.0 | 49.0 ± 2.7 | |
| Secondary outcomes | |||
| Ponderal index5 | 2.7 ± 0.4 | 2.7 ± 0.3 | 0.170 |
| Male (%) | 54 | 49 | NS |
| Cord RBC-phospholipid-DHA (%) | 5.9 ± 1.4 | 7.3 ± 1.8 | 0.001 |
| Head circumference (cm) | 33.7 ± 2.0 | 34.2 ± 1.7 | 0.012 |
| Preterm birth (%)6 | 8.8 | 7.8 | NS |
| Gestation <34 wk (%) | 4.8 | 0.6 | 0.025 |
| Birth weight <2500 g (%) | 9.0 | 3.9 | 0.059 |
| Birth weight <1500 g (%) | 3.4 | 0.0 | 0.026 |
| Admitted to NICU (%) | 8.8 | 8.4 | NS |
| NICU admissions (hospital d) | 38.4 | 7.8 | 0.034 |
| Preterm infants (hospital d) | 40.8 ± 44.0 | 8.9 ± 10.1 | 0.026 |
| C-section birth (%) | 29.9 | 29.9 | NS |
| Labored on own (%) | 60 | 56.5 | NS |
| Preeclampsia (%) | 1.3 | 1.3 | NS |
| Gestational diabetes (%) | 4.1 | 5.6 | NS |
| Capsules (no./wk) | 15.2 ± 5.8 | 15.7 ± 5.6 | NS |
| Study capsule intake (no.) | 354 ± 147 | 370 ± 152 | NS |
NICU, neonatal intensive care unit; RBC, red blood cell.
Mean differences between placebo and DHA-supplemented groups were tested with a 2-sample one-sided t test and no covariate for primary efficacy outcomes and for secondary efficacy outcomes of cord RBC-phospholipid-DHA and head circumference. Other secondary efficacy outcomes were tested with one-sided binomial exact tests. One-tailed P values at α = 0.05 were considered significant. To evaluate days of hospitalization after preterm birth, we used bootstrap procedures assuming unequal variances. All outcomes used intent-to-treat principles.
g/100 g total fatty acids.
The data were not analyzed separately by race.
Weight (g)/length (cm)3 × 100.
Defined as <37 wk of gestation.