TABLE 1.
Baseline characteristics of participants who received the allocated intervention1
| Choline (n = 31) | Placebo (n = 29) | |
| Age, y | 3.79 ± 0.802 | 3.92 ± 0.76 |
| Sex, n (%) | ||
| M | 12 (39) | 10 (35) |
| F | 19 (61) | 19 (65) |
| Racial categories, n (%) | ||
| White | 16 (52) | 9 (31) |
| Black or African American | 5 (16) | 9 (31) |
| American Indian/Alaska Native | 4 (13) | 7 (24) |
| Asian | 1 (3) | 1 (4) |
| More than one race | 5 (16) | 3 (10) |
| Ethnic category, n (%) | ||
| Hispanic or Latino | 1 (3) | 1 (3) |
| Not Hispanic or Latino | 29 (94) | 27 (93) |
| Unknown | 1 (3) | 1 (4) |
| Dysmorphic facial features, n (%) | ||
| Lip (score of 4 or 5) | 16 (52) | 10 (35) |
| Philtrum (score of 4 or 5) | 13 (42) | 9 (31) |
| Palpebral fissure (≤10th percentile)3 | 21 (68) | 20 (69) |
| ≥2 facial features present | 20 (65) | 17 (59) |
| Growth deficiency (≤10th percentile), n (%) | ||
| Height3 | 4 (13) | 0 (0) |
| Weight | 5 (16) | 1 (3) |
| Deficient brain growth (≤10th percentile) OFC,3 n (%) | 3 (10) | 0 (0) |
| Alcohol exposure, n (%) | ||
| Alcohol confirmed | 24 (77) | 26 (90) |
| Alcohol suspected | 7 (23) | 3 (10) |
| Drug exposure, n (%) | ||
| Other drug exposure suspected | 21 (68) | 21 (72) |
| IOM diagnostic category, n (%) | ||
| FAS | 5 (16) | 5 (17) |
| Partial FAS | 15 (48) | 11 (38) |
| ARND | 11 (36) | 13 (45) |
| Baseline cognitive-functioning scores4 | ||
| Mullen Visual Reception | 41 ± 12 | 44 ± 16 |
| Mullen Fine Motor | 42 ± 9 | 40 ± 15 |
| Mullen Receptive Language | 41 ± 9 | 40 ± 12 |
| Mullen Expressive Language | 40 ± 8 | 41 ± 11 |
| Mullen Early Learning Composite | 83 ± 14 | 84 ± 21 |
1
ARND, alcohol-related neurodevelopmental disorder; FAS, fetal alcohol syndrome; IOM, Institute of Medicine; OFC, occipital-frontal circumference.
2
Mean ± SD (all such values).
3
Data from the study baseline were missing from participants who were uncooperative and from whom an accurate measure could not be obtained for palpebral fissure length (choline: n = 3), height (choline: n = 1), and OFC (choline: n = 1). Data acquired from previous clinical evaluations are included for these participants.
4
Data were missing for 2 participants (choline: n = 2) who were unable to finish testing.