Since the 2005 FDA approval for adult PAH, and despite a 2012 black box warning against long-term use in 1- to 7-year-old children due to increased risk of death at high doses, there has been an increasing trend of utilizing the off-label preparation of sildenafil in infants [ 25 , 26 ].
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Prophylactic Sildenafil in Preterm Infants at Risk of Bronchopulmonary Dysplasia: A Pilot Randomized, Double-Blinded, Placebo-Controlled Trial.
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