Table III. Nutrition and growth.
Outcome | SMOF-LE (n = 110) | S-LE (n = 113) | P |
---|---|---|---|
Study drug and nutrition | |||
Therapy adherence >80% | 109 (99) | 110 (97) | .33 |
Time on PN (d) | 23 [17-37] | 24 [17-35] | .87 |
Time on parenteral lipids (d) | 20 [15-35] | 21 [15-29] | .91 |
Total parenteral lipids (g/kg) | 38.2 [26.4-68.5] | 39.0 [28.1-55.3] | .56 |
Total study lipids (g/kg) | 32.6 [21.3-63.8] | 34.4 [23.0-50.8] | .57 |
Highest triglycerides (mg/dL) | 208 [142-323] * | 207 [147-305] † | .85 |
Parenteral lipids at measurement | 2.1 [1.5-2.5]* | 2.0 [1.2-2.5]† | .30 |
Hypertriglyceridemia | 39 (39) | 38 (37) | .71 |
Feeding first wk (mL per feed/kg) | 3.3 [2.3-4.1] | 3.1 [2.3-4.1] | .55 |
Mothers milk at discharge (any) | 85 (75) | 80 (69) | .29 |
Anthropometry at discharge ‡ | |||
Weight at discharge (g) | 2594 [2124 to 3029] | 2479 [2175 to 2956] | .23 |
Δ z score (birth to end of study) | −0.7 [−1.0 to −0.2] | −0.7 [−1.1 to −0.2] | .84 |
Length (cm) | 45 [42.5 to 47] | 44 [41.5 to 47] | .14 |
Δ z Score (birth to end of study) | −1.4 [−2.3 to 0.8] | −1.5 [−2.1 to 1.0] | .64 |
Head circumference (cm) | 32 [30.6 to 33.5] | 32 [30.7 to 33.1] | .45 |
Δ z Score (birth to end of study) | −1.0 [−1.7 to −0.3] | −1.0 [−1.6 to −0.3] | .92 |
Analysis by ITT. Categorical data are presented as numbers with percentages in round parentheses and were tested using the χ2 test. Continuous data are presented as median and IQR in squared parentheses and were tested using the Mann-Whitney U Test. P values <.05 were considered statistically significant.
Data of 11 patients missing.
Data of 10 patients missing.
For analysis of growth, infants who died were excluded (SMOF-LE, n = 104; S-LE, n = 101).