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Table 1 Number of Participants (N) and Dosing Scheme

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

Cohorta Treatment Group Sildenafil Dosingb
(mg/kg q 8 h)
Total (N)
Placebo (N) Sildenafil (N) IV Enteral
1 10 30 0.5 1 40
2 10 30 1 2 40
3 10 30 2 4 40
  1. Abbreviations: IV intravenous, N number of participants, q every
  2. aParticipants will be enrolled into cohorts sequentially (i.e., Cohort 1 then Cohort 2 then Cohort 3) based on safety
  3. bRoute of administration should be via IV route if patient has an IV and IV administration is feasible. However, route of administration, IV or enteral, is left to investigator discretion