Table 1.
Clinical data
| Variablea | Cohort 1 (n = 25) | Cohort 2 (n = 9) | All (n = 34) |
|---|---|---|---|
| Dose (mg/kg)b | 0.95 [0.42–2.09] | 0.25 [0.13–0.25] | 0.79 [0.13–2.09] |
| Dose (mg/kg/d)b | 3.49 [1.25–8.38] | 0.25 [0.13–0.25] | 2.79 [0.13–8.38] |
| Samples per infantc | 3 [3–4] | 3 [2–4] | 3 [2–4] |
| Weight (kg) | 4.79 [1.36–8.06] | 0.75 [0.59–1.24] | 3.41 [0.59–8.06] |
| Birth weight (g) | 650 [450–1215] | 800 [425–980] | 666 [425–1215] |
| Gestational age (wk) | 25 [22–28] | 25 [23–27] | 25 [22–28] |
| Postnatal age (d) | 166 [52–279] | 18 [7–40] | 125.5 [7–279] |
| Postmenstrual age (wk) | 47.0 [31.3–62.7] | 27.4 [26.0–32.4] | 41.6 [26.0–62.7] |
| Serum creatinine (mg/dL)d | 0.2 [0.1–0.7] | 0.6 [0.4–1.4] | 0.3 [0.1–1.4] |
| Albumin (g/dL)c | 3.7 [1.8–4.3] | 2.8 [1.7–3.7] | 3.1 [1.7–4.3] |
| Fluconazole, n (%) | 0 | 4 (44%) | 4 (12%) |
| Formulation, n (%) | |||
| Enteral | 24 (96%) | 0 | 24 (71%) |
| Intravenous | 1 (4%) | 9 (100%) | 10 (29%) |
a
Descriptive statistics were calculated based on the value at the time of first record for each infant and reported as median [range] for continuous variables and n (%) for categorical variables. Fluconazole (%) was reported as the percentage of concomitant use of fluconazole in each group.
b
Doses (mg/kg and mg/kg/d) are calculated based on the first recorded dose.
Calculated from a total of 109 plasma pharmacokinetic samples collected, including 4 and 2 samples that were below the quantification limit for sildenafil and N‐desmethyl sildenafil, respectively.
Serum creatinine data were missing for 5 (15%) infants.
c
Albumin data were missing for 15 (44%) infants.