TABLE 2.
Baseline characteristics and trial outcomes of all infants who completed primary outcome assessments1
| Adjusted mean difference2 |
|||||||
| Inc-AA/SO | Inc-AA/SMOF | Imm-RDI/SO | Imm-RDI/SMOF | Imm-RDI − Inc-AA | SMOF − SO | Interaction | |
| Infants, n | 34 | 28 | 34 | 37 | |||
| Gestational age, wk | 28.0 (27.3, 28.6) | 28.0 (27.2, 28.9) | 28.4 (27.7, 29.2) | 27.7 (27.1, 28.4) | |||
| Birth weight, g | 1064 (962, 1166) | 1103 (979, 1226) | 1090 (993, 1186) | 1059 (962, 1155) | |||
| Male, % | 58.8 (40.7, 75.4) | 64.3 (44.1, 81.4) | 50.0 (33.4, 67.6) | 51.4 (34.4, 67.5) | |||
| Age at scan, wk | 12.5 (11.3, 13.7) | 12.4 (10.9, 14.0) | 12.1 (10.8, 13.4) | 13.3 (12.0, 14.5) | |||
| Primary outcomes | |||||||
| Nonadipose mass, g | 2450 (2246, 2655) | 2337 (2164, 2510) | 2344 (2244, 2444) | 2485 (2327, 2643) | 1 (−108, 111); P = 0.98 | −41 (−150, 68); P = 0.46 | 216 (0, 432); P = 0.05 |
| IHCL3 | 0.6 (0.4, 0.9); n = 34 | 0.7 (0.5, 1.0); n = 28 | 0.5 (0.4, 0.6); n = 34 | 0.5 (0.3, 0.7); n = 36 | 0.7 (0.5, 1.1); n = 132; P = 0.11 | 1.1 (0.8, 1.6); n = 132; P = 0.58 | 0.8 (0.4, 1.7); n = 132; P = 0.53 |
| Secondary outcomes | |||||||
| Total cerebral volume,4 cm3 | 468 (419, 518); n = 13 | 480 (425, 534); n = 10 | 468 (414, 523); n = 11 | 511 (440, 583); n = 15 | 15 (−42, 71); n = 49; P = 0.61 | 24 (−32, 80); n = 49; P = 0.40 | −26 (−142, 90); n = 49; P = 0.66 |
| Whole brain volume,5 cm3 | 339 (304, 373); n = 13 | 352 (319, 385); n = 10 | 344 (296, 393); n = 11 | 365 (321, 410); n = 15 | 9 (−29, 47); n = 49; P = 0.64 | 14 (−24, 52); n = 49; P = 0.47 | −29 (−107, 49); n = 49; P = 0.46 |
| Posterior fossa volume,6 cm3 | 30 (26, 33); n = 13 | 31 (28, 34); n = 10 | 30 (27, 34); n = 11 | 35 (29, 38); n = 15 | 1.44 (−1.99, 4.87); n = 49; P = 0.41 | 2 (−2, 5); n = 49; P = 0.35 | −2 (−9, 5); n = 49; P = 0.64 |
| QUICKI score | 0.18 (0.17, 0.19); n = 11 | 0.19 (0.18, 0.20); n = 6 | 0.19 (0.18, 0.20); n = 11 | 0.18 (0.17, 0.20); n = 11 | 0.01 (0, 0.02); n = 39; P = 0.20 | 0.01 (−0.01, 0.02); n = 39; P = 0.28 | −0.01 (−0.04, 0.02); n = 39; P = 0.46 |
| Weight, g | 3060 (2780, 3340) | 2924 (2686, 3162) | 2932 (2780, 3085) | 3151 (2934, 3368) | 17 (−136, 170); P = 0.83 | −35 (−187, 117); P = 0.65 | 293 (−8, 593); P = 0.06 |
| Length, cm | 47.7 (46.4, 49.0) | 48.0 (46.6, 49.4) | 48.2 (47.4, 49.0) | 49.1 (47.8, 50.3) | 0.5 (−0.3, 1.3); P = 0.20 | 0.2 (−0.6, 1.0); P = 0.56 | 0.5 (−1.1, 2.1); P = 0.56 |
| Head circumference, cm | 36.0 (34.9, 37.1) | 35.3 (34.6, 36.0) | 34.8 (34.3, 35.3) | 35.2 (34.5, 35.9) | −0.8 (−1.5, −0.1); P = 0.02 | −0.2 (−0.9, 0.5); P = 0.56 | 1.1 (−0.2, 2.5); P = 0.09 |
| Superficial subcutaneous adipose tissue, g | 515 (437, 593) | 495 (431, 559) | 493 (431, 554) | 564 (499, 629) | 12 (−44, 68); P = 0.67 | 9 (−46, 64); P = 0.75 | 73 (−38, 183); P = 0.20 |
| Internal adipose tissue, g | 67.2 (55.5, 79.0) | 65.0 (52.4, 77.5) | 69.1 (57.2, 81.0) | 71.2 (59.8, 82.5) | 2.5 (−7.5, 12.6); P = 0.62 | −3.4 (−13.4, 6.6); P = 0.50 | 0.1 (−19.9, 20.1); P = 0.99 |
| Deep subcutaneous abdominal adipose tissue, g | 14.2 (11.0, 17.3) | 13.0 (10.7, 15.2) | 14.9 (12.3, 17.5) | 17.8 (14.8, 20.7) | 2.0 (−0.5, 4.4); P = 0.11 | 0.4 (−2.0, 2.8); P = 0.74 | 3.5 (−1.3, 8.3); P = 0.15 |
| Internal abdominal adipose tissue, g | 14.8 (12.2, 17.3) | 14.1 (11.0, 17.2) | 15.9 (12.8, 18.9) | 16.5 (13.6, 19.3) | 1.4 (−1.2, 4.1); P = 0.28 | −0.8 (−3.4, 1.8); P = 0.56 | 0.5 (−4.8, 5.7); P = 0.86 |
| Superficial subcutaneous abdominal adipose tissue, g | 87.0 (72.4, 101.6) | 84.5 (72.8, 96.2) | 85.2 (73.8, 96.5) | 102.6 (87.2, 118.1) | 5.2 (−6.5, 17.0); P = 0.38 | 5.0 (−6.7, 16.6); P = 0.40 | 16.3 (−7.0, 39.6); P = 0.17 |
| Total adipose tissue, g | 610 (518, 702) | 587 (509, 664) | 589 (514, 663) | 666 (589, 743) | 16 (−51, 82); P = 0.64 | 6 (−60, 72); P = 0.85 | 77 (−55, 208); P = 0.25 |
| Total adipose tissue as % of body weight | 19.4 (17.9, 20.9) | 19.7 (18.4, 21.0) | 19.6 (17.8, 21.4) | 20.8 (19.4, 22.3) | 0 (−0.01, 0.02); P = 0.56 | 0.01 (−0.01, 0.02); P = 0.45 | 0.01 (−0.02, 0.03); P = 0.72 |
| Safety outcomes,7 % | |||||||
| Triglycerides >2.5 mmol/L | 29.4 (15.1, 47.5) | 25.0 (10.7, 44.9) | 32.4 (17.4, 50.5) | 27.0 (13.8, 44.1) | 1.15 (0.48, 2.74); P = 0.76 | 0.68 (0.28, 1.62); P = 0.38 | 0.71 (0.12, 4.06); P = 0.70 |
| Total serum bilirubin >150 μmol/L | 70.6 (52.5, 84.9) | 75.0 (55.1, 89.3) | 67.6 (49.5, 82.6) | 75.7 (58.8, 88.2) | 0.92 (0.41, 2.04); P = 0.83 | 1.32 (0.59, 2.94); P = 0.50 | 1.29 (0.26, 6.47); P = 0.75 |
| Conjugated bilirubin >40 μmol/L | 11.8 (3.3, 27.5) | 10.7 (2.3, 28.2) | 5.9 (0.7, 19.7) | 8.1 (1.7, 21.9) | 0.47 (0.12, 1.85); P = 0.28 | 0.93 (0.24, 3.54); P = 0.92 | 1.65 (0.11, 25.34); P = 0.72 |
| Alanine aminotransferase >60 IU/L | 8.8 (1.9, 23.7) | 7.1 (0.9, 23.5) | 8.8 (1.9, 23.7) | 5.4 (0.7, 18.2) | 0.99 (0.22, 4.41); P = 0.99 | 0.45 (0.09, 2.12); P = 0.31 | 0.59 (0.03, 12.69); P = 0.74 |
Values are means; 95% CIs in parentheses unless otherwise indicated. Multiple regression was used for modeling. IHCL, intrahepatocellular lipid; Imm-RDI, immediate recommended daily intake; Inc-AA, incremental introduction of amino acid; QUICKI, quantitative insulin sensitivity check index; SMOF, soybean oil, medium-chain triglycerides, olive oil, and fish oil; SO, soybean-based lipid emulsion.
Adjusted for age at scan, sex, gestational age, birth weight, and center; body mass components are derived from body mass volumes.
Log transformation was used in the regression model with the results transformed back from the log scale.
Total of basal ganglia, thalami (deep gray matter), cerebrospinal fluid, gray matter, white matter, and lateral ventricles volumes.
Total of basal ganglia, thalami (deep gray matter), gray matter, and white matter.
Total of cerebellum and brainstem volumes.
Values are percentages; 95% CIs in parentheses. Logistic regression was used for modeling, and ORs are reported.