Table 1.
Characteristics at study enrollment of the subsample with usable ERP data.
| N(%) or mean (SD) | Participants with ERP data at completion (9-month assessment) (n = 24) | Participants without ERP data at completion (9-month assessment) (n = 16) | |
|---|---|---|---|
| Age at enrollment (years) | 3.97 (0.85) | 3.43 (0.69) | t(38) = −2.14, p = 0.039 |
| Gender | |||
| Male | 7 (29%) | 8 (50%) | p = 0.205 |
| Female | 17 (71%) | 8 (50%) | |
| Racial Categories | |||
| White | 4 (17%) | 10 (63%) | p = 0.007 |
| Black or African American | 6 (25%) | 4 (25%) | |
| American Indian/Alaska Native | 7 (29%) | 0 (0%) | |
| Asian | 1 (4%) | 1 (6%) | |
| More than one race | 6 (25%) | 1 (6%) | |
| Ethnic Category | |||
| Hispanic or Latino | 0 (0%) | 0 (0%) | p = 0.508 |
| Not Hispanic or Latino | 22 (92%) | 16 (100%) | |
| Unknown | 2 (8%) | 0 (0%) | |
| Dysmorphic Facial Features | |||
| Lip (score 4 or 5) | 12 (50%) | 8 (50%) | p = 1.000 |
| Philtrum (score 4 or 5) | 10 (42%) | 6 (38%) | p = 1.000 |
| Palpebral Fissure (≤10th percentile) 1 | 18 (75%) | 12 (75%) | p = 1.000 |
| ≥ 2 Facial Features Present | 13 (54%) | 8 (50%) | p = 1.000 |
| Growth Deficiency (≤10th percentile) | |||
| Height 1 | 1 (4%) | 1 (6%) | p = 1.000 |
| Weight | 1 (4%) | 1 (6%) | p = 1.000 |
| Deficient Brain Growth (≤10th percentile) | |||
| Occipital-Frontal Circumference (OFC) | 0 (0%) | 1 (6%) | p = 0.400 |
| Alcohol Exposure | |||
| Alcohol Confirmed | 18 (75%) | 15 (94%) | p = 0.210 |
| Alcohol Suspected | 6 (25%) | 1 (6%) | |
| Drug Exposure | |||
| Other Drug Exposure Suspected | 20 (83%) | 9 (56%) | p = 0.80 |
| IOM Diagnostic Category 1 | |||
| FAS | 0 (0%) | 4 (25%) | p = 0.041 |
| Partial FAS | 14 (58%) | 7 (44%) | |
| ARND | 10 (42%) | 5 (31%) | |
| Treatment Group | |||
| Choline | 11 (46%) | 10 (62%) | p = 0.289 |
| Placebo | 13 (54%) | 6 (38%) | |
| Baseline Cognitive Functioning 2 | |||
| Mullen Visual Reception | 43 (12) | 33 (11) | t(36) = −2.53, p = 0.016 |
| Mullen Fine Motor | 40 (12) | 37 (13) | t(36) = −0.77, p = 0.445 |
| Mullen Receptive Language | 41 (11) | 32 (8) | t(36) = −2.49, p = 0.018 |
| Mullen Expressive Language | 43 (9) | 36 (9) | t(36) = −2.52, p = 0.016 |
| Mullen Early Learning Composite | 85 (17) | 72 (13) | t(36) = −2.48, p = 0.018 |
Comparisons between treatment groups were conducted using Independent Samples t-tests for continuous variables and Fisher’s Exact Test for categorical variables.
1
FAS: Fetal Alcohol Syndrome; ARND: Alcohol-Related Neurodevelopmental Disorder.
2
n = 2 in the group without ERP data did not have Mullen data at enrollment.