TABLE 1.
Clinical data for study subjectsa
| Characteristic | All subjects | Subjects on ECMO support | Subjects not on ECMO |
|---|---|---|---|
| n (%) | 40 (100) | 21 (53) | 19 (47) |
| Body wt (kg) | 3.4 (1.9, 77) | 4.2 (2.0, 77) | 3.2 (1.9, 8.0) |
| Postnatal age (days) | 22 (1, 6,498) | 113 (1, 6,498) | 13 (1, 262) |
| Gestational age (wk)b | 38 (24, 41) | 38 (30, 41) | 37 (24, 40) |
| Postmenstrual age (wk) | 41 (35, 76) | 42 (36, 63) | 39 (35, 76) |
| Female | 14 (35) | 7 (33) | 7 (37) |
| Race | |||
| White | 17 (43) | 9 (43) | 8 (42) |
| African-American | 18 (45) | 10 (48) | 8 (42) |
| Other | 5 (12) | 2 (9) | 3 (16) |
| Indication | |||
| Prophylaxis | 23 (57) | 17 (81) | 6 (32) |
| Treatment | 17 (43) | 4 (19) | 13 (68) |
| First dose (mg/kg) | 25 (2.7, 26.5) | 25.0 (10.4, 25.7) | 17.4 (2.7, 26.5) |
| PK sample collection period (days)c | 5.5 (2.0, 34.0) | 8.8 (2.1, 21.3) | 4.2 (2.0, 34.0) |
| No. of PK samples per child | 8 (1, 22) | 11 (5, 22) | 8 (1, 14) |
| Serum creatinine level (mg/dl) | |||
| Initiald | 0.4 (0.1, 1.3) | 0.5 (0.1, 1.2) | 0.3 (0.1, 1.3) |
| Maximum | 0.6 (0.1, 3.2) | 0.7 (0.3, 3.2) | 0.5 (0.1, 1.3) |
| Albumin level (g/dl) | 2.7 (1.1, 4.0) | 2.8 (2.0, 4.0) | 2.7 (1.1, 3.1) |
| Aspartate aminotransferase level (U/liter) | 35 (15, 673) | 39 (23, 673) | 35 (15, 159) |
| Alanine aminotransferase level (U/liter) | 19 (8, 127) | 16 (8, 127) | 19 (8, 126) |
a
Values are median (range) for continuous variables and no. (%) for categorical variables.
b
Gestational age is reported only for infants <1 year of age (n = 33).
c
Sample collection period is the time between first dose of study drug and collection of last PK sample.
d
Initial serum creatinine collected within 24 h of first dose.