Long-term follow-up of a randomized controlled trial of choline for neurodevelopment in fetal alcohol spectrum disorder: corpus callosum white matter microstructure and neurocognitive outcomes

Table 2 Demographic characteristics of participants included in analyses

N(%) or mean (SD)	Choline (n = 9)	Placebo (n = 9 )	Statistical test
Age at enrollment (years)^a	3.54 (0.91)	4.18 (0.66)	t(15) = −1.70, p = 0.11
Age at follow-up evaluation (years)	10.56 (1.81)	11.44 (1.67)	t(15) = −1.08, p = 0.29
Total intracranial volume cm3^b	1461.9 (119.6)	1437.7 (74.9)	t(13) = 0.51, p = 0.61
Intelligence quotient^c	90.5 (10.2)	83.56 (21.63)	t(12) = 0.86, p = 0.41
Sex (female)	5 (55.6%)	5 (55.6%)	χ² (1) = 0, p = 1.00
Ethnicity (Hispanic)	1 (11.1%)	1 (11.1%)	χ² (2) = 1.07, p = 0.59
Race^d
American Indian/Alaska Native	0	3 (33.3%)	χ² (1) = 5.63, p = 0.02
Asian	1 (11.1%)	1 (11.1%)	χ² (1) = 0.89, p = 0.35
Black or African American	0	2 (22.2%)	χ² (1) = 4.44, p = 0.04
White	5 (56.6%)	1 (11.1%)	χ² (1) = 4, p = 0.04
Multiracial	2 (22.2%)	2 (22.2%)	χ² (1) = 1.27, p = 0.26
Unknown	1 (11.1%)	0	χ² (1) = 0.19, p = 0.66
Handedness (right)^e	8 (88.9%)	7 (77.8%)	χ² (1) = 2.01, p = 0.16
IOM diagnostic category			χ² (2) = 0.90, p = 0.63
FAS	2 (22.2%)	3 (33.3%)
Partial FAS	2 (22.2%)	3 (33.3%)
ARND	5 (56.6%)	3 (33.3%)
Physical characteristics
^fGrowth deficiency	3 (33.3%)	4 (44.4%)	χ² (1) = 0.23, p = 0.63
^gMicrocephaly	4 (44.4%)	5 (56.6%)	χ² (1) = 0.22, p = 0.64
^hDysmorphic face	4 (44.4%)	6 (66.7%)	χ² (1) = 0.90, p = 0.34

Demographics are from the 18 participants included in the analyses. Age at follow-up evaluation ranged from 8 to 15 years. Participants were excluded from this analysis if significant data were missing. Of the initial eligible pool of 20 participants who returned for follow-up, two participants who did not complete neuroimaging were eliminated
^aAge at enrollment = age at initial clinical trial enrollment (participants age 2.5–5)
^bTotal intracranial volume = total intracranial volume at time point at follow-up evaluation
^cIntelligence quotient was measured at the 4-year follow-up visit (full-scale IQ standard score)
^dChi-square tests reflect comparisons of each racial group to the proportion of participants who identified as White (e.g., proportion of participants who identified as multiracial to proportion of those who identified as White)
^eMissing handedness data for two participants
^fHeight or weight ≤ 10%ile
^gHead circumference ≤ 10%ile
^hAt least two of the following: palpebral fissure length ≤ 10%ile, thin vermillion border, smooth philtrum (4 or 5 on lipometer scale)

ISSN: 1866-1955