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

Table 1 Number of Participants (N) and Dosing Scheme

Cohort^a	Treatment Group		Sildenafil Dosing^b (mg/kg q 8 h)		Total (N)
Cohort^a	Placebo (N)	Sildenafil (N)	IV	Enteral	Total (N)
1	10	30	0.5	1	40
2	10	30	1	2	40
3	10	30	2	4	40

Abbreviations: IV intravenous, N number of participants, q every
^aParticipants will be enrolled into cohorts sequentially (i.e., Cohort 1 then Cohort 2 then Cohort 3) based on safety
^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

ISSN: 1471-2431