Table 2.
12 week outcomes | 24 week outcomes | 52 week outcomes | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Predictors | B | SE B | β | t | 95% CI | B | SE B | β | t | 95% CI | B | SE B | β | t | 95% CI |
MSEL a gross motor | |||||||||||||||
Milk thiamine at 2 weeks b | 0.00 | 0.01 | 0.01 | 0.17 | [−0.01, 0.01] | −0.01 | 0.01 | −0.08 | −1.33 | [−0.02, 0.00] | −0.01 | 0.01 | −0.04 | −0.62 | [−0.02, 0.01] |
MSEL gross motor at 2 weeks | 0.06 | 0.05 | 0.06 | 1.08 | [−0.05, 0.17] | 0.19 | 0.06 | 0.19 | 3.29*** | [0.08, 0.30] | 0.00 | 0.01 | 0.001 | 0.01 | [−0.17, 0.17] |
Tx thiamine dosage | 0.07 | 0.10 | 0.04 | 0.72 | [−0.12, 0.27] | 0.03 | 0.11 | 0.02 | 0.30 | [−0.18, 0.24] | −0.07 | 0.16 | −0.02 | −0.42 | [−0.38, 0.25} |
R 2 = 0.01, F(3, 306) = 0.56, P = 0.64 | R 2 = 0.04, F(3, 294) = 4.21, P = 0.01 | R 2 = 0.00, F(3, 306) = 0.19, P = 0.91 | |||||||||||||
MSEL a fine motor | |||||||||||||||
Milk thiamine at 2 weeks b | 0.00 | 0.01 | 0.00 | 0.06 | [−0.01, 0.01] | 0.01 | 0.01 | 0.14 | 2.48** | [0.00, 0.02] | −0.01 | 0.01 | −0.08 | −1.34 | [−0.03, 0.01] |
MSEL fine motor at 2 weeks | 0.17 | 0.08 | 0.13 | 2.26* | [0.02, 0.32] | 0.14 | 0.06 | 0.13 | 2.27* | [0.02, 0.26] | 0.22 | 0.11 | 0.10 | 2.03* | [−0.02, 0.44] |
Tx thiamine dosage | −0.02 | 0.12 | −0.01 | −0.15 | [−0.25, 0.21] | 0.11 | 0.10 | 0.07 | 1.19 | [−0.07, 0.30] | 0.15 | 0.17 | 0.05 | 0.84 | [−0.20, 0.49] |
R 2 = 0.02, F(3, 306) = 1.70, P = 0.17 | R 2 = 0.04, F(3, 294) = 4.38, P = 0.01 | R 2 = 0.02, F(3, 306) = 2.02, P = 0.08 | |||||||||||||
MSEL a visual reception | |||||||||||||||
Milk thiamine at 2 weeks b | −0.01 | 0.01 | −0.05 | −0.94 | [−0.03, 0.01] | 0.00 | 0.01 | −0.01 | −0.09 | [−0.01, 0.01] | 0.00 | 0.01 | 0.00 | 0.01 | [−0.02, 0.02] |
MSEL visual reception at 2 weeks | −0.18 | 0.16 | −0.06 | −1.09 | [−0.50, 0.14] | 0.06 | 0.11 | 0.04 | 0.60 | [−0.14, 0.27] | 0.14 | 0.21 | 0.04 | 0.65 | [−0.28, 0.55] |
Tx thiamine dosage | −0.06 | 0.16 | −0.02 | −0.40 | [−0.37, 0.24] | −0.07 | 0.10 | −0.04 | −0.75 | [−0.26, 0.12] | −0.16 | 0.20 | −0.05 | −0.79 | [−0.55, 0.24] |
R 2 = 0.00, F(3, 306) = 0.75, P = 0.52 | R 2 = 0.00, F(3, 294) = 0.47, P = 0.81 | R 2 = 0.00, F(3, 306) = 0.34, P = 0.79 | |||||||||||||
MSEL a receptive language | |||||||||||||||
Milk thiamine at 2 weeks b | 0.02 | 0.01 | 0.10 | 2.03* | [0.00, 0.03] | 0.03 | 0.01 | 0.17 | 3.04*** | [0.01, 0.05] | 0.00 | 0.01 | 0.03 | 0.49 | [−0.01, 0.02] |
MSEL receptive language at 2 weeks | 0.15 | 0.07 | 0.12 | 2.11* | [0.01, 0.29] | 0.22 | 0.08 | 0.15 | 2.70** | [0.06, 0.37] | 0.03 | 0.06 | 0.02 | 0.42 | [−0.09, 0.14] |
Tx thiamine dosage | 0.19 | 0.15 | 0.07 | 1.31 | [−0.10, 0.47] | 0.39 | 0.17 | 0.14 | 2.54** | [0.09, 0.74] | −0.04 | 0.13 | −0.02 | −0.35 | [−0.29, 0.20] |
R 2 = 0.02, F(3, 306) = 3.16, P = 0.02 | R 2 = 0.07, F(3, 294) = 7.88, P < 0.00 | R 2 = 0.00, F(3, 306) = 0.18, P = 0.91 | |||||||||||||
MSEL a expressive language | |||||||||||||||
Milk thiamine at 2 weeks b | −0.00 | 0.01 | −0.03 | −0.58 | [−0.02, 0.01] | 0.01 | 0.01 | 0.14 | 2.45** | [0.00, 0.03] | 0.00 | 0.01 | 0.02 | 0.30 | {−0.01, 0.02] |
MSEL expressive language at 2 weeks | −0.31 | 0.33 | −0.05 | −0.94 | [−0.97, 0.34] | −0.44 | 0.27 | −0.09 | −1.62 | [−0.98, 0.10] | −0.30 | 0.40 | −0.04 | −0.74 | [−0.49, − 1.09] |
Tx thiamine dosage | 0.10 | 0.13 | 0.05 | 0.78 | [−0.15, 0.35] | 0.19 | 0.10 | 0.11 | 2.07* | [0.01, 0.39] | −0.13 | 0.14 | −0.05 | −0.97 | [−0.40, 0.14] |
R 2 = 0.01, F(3, 306) = 0.58, P = 0.63 | R 2 = 0.04, F(3, 294) = 3.65, P = 0.01 | R 2 = 0.01, F(3, 306) = 0.50, P = 0.69 | |||||||||||||
CREDI c | |||||||||||||||
Milk thiamine at 2 weeks b | 0.00 | 0.00 | 0.03 | 0.51 | [−0.00, 0.00] | 0.01 | 0.00 | 0.18 | 3.11** | [0.00, 0.01] | 0.01 | 0.00 | 0.13 | 2.15* | [0.00, 0.01] |
CREDI or MSEL at baseline d | 0.02 | 0.01 | 0.09 | 1.64 | [−0.00, 0.04] | 0.20 | 0.06 | 0.18 | 3.18** | [0.08, 0.33] | 0.20 | 0.08 | 0.14 | 2.42* | [0.04, 0.36] |
Tx thiamine dosage | 0.01 | 0.03 | 0.01 | 0.23 | [−0.05, 0.06] | 0.02 | 0.03 | 0.03 | 0.63 | [−0.05, 0.08] | 0.00 | 0.04 | 0.01 | 0.07 | [−0.09, 0.08] |
R 2 = 0.01, F(3, 306) = 1.01, P = 0.39 | R 2 = 0.07, F(3, 294) = 6.79, P < 0.00 | R 2 = 0.04, F(3, 289) = 3.51, P = 0.02 |
Note: Table results are based on linear regression analyses. Results in the shaded columns associated with 24 weeks are highlighted because 24 weeks was our primary, preregistered outcome time point for the present trial, and corresponded with the end of the thiamine supplementation trial. The 6 months between 24 and 52 weeks coincided with the postintervention period. Significant effects are presented in bold font. SE, standard error.
MSEL, Mullen Scales of Early Learning.
Human milk total thiamine concentrations were calculated as free thiamine + (thiamine monophosphate × 0.871) + (thiamine diphosphate × 0.707).
CREDI, Caregiver Report of Early Development Instrument.
CREDI at 2 weeks was not available; therefore, we used the baseline Mullen ELC score as our autoregressive term when predicting infants’ CREDI scores at 12 weeks in both Model 1 and Model 2. Infants’ CREDI score at 12 weeks was used as the autoregressive terms in models predicting CREDI scores at 24 and 52 weeks.
P < 0.05; ** P < 0.01; *** P < 0.001.