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Table 2 Dose Escalations for Each Sequential Cohort

From: Safety of sildenafil in premature infants with severe bronchopulmonary dysplasia (SILDI-SAFE): a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study

 

Study Days (Dose Numbers)

1–2 (1–6)

3–4 (7–12)

5–6 (13–18)

7–8 (19–24)

9–10 (25–30)

11–12 (31–36)

13–14 (37–42)

15 + (43 +)

Sildenafil Dose (mg/kg)

 Cohort 1

 IV

0.25

0.5

0.5

0.5

0.5

0.5

0.5

0.5

 Enteral

0.5

1

1

1

1

1

1

1

 Cohort 2

 IV

0.25

0.5

0.75

1

1

1

1

1

 Enteral

0.5

1

1.5

2

2

2

2

2

 Cohort 3

 IV

0.25

0.5

0.75

1

1.5

1.75

2

2

 Enteral

0.5

1

1.5

2

3

3.5

4

4

  1. Abbreviation: IV intravenous
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BMC Pediatrics

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