6ER-013 A pilot randomised double-blinded placebo-controlled trial of prophylactic sildenafil in preterm infants at risk of bronchopulmonary dysplasia

BackgroundBronchopulmonary dysplasia (BPD) is associated with poor long-term neurodevelopmental outcomes and an increased readmission risk because of respiratory conditions. Since the 2005 FDA approval of sildenafil for adults with pulmonary artery hypertension, and despite a 2012 black box warning...

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Bibliographic Details
Published in:European journal of hospital pharmacy. Science and practice 2019-03, Vol.26 (Suppl 1), p.A283-A284
Main Authors: Abou-Nahia, F, Abu-Jarir, R, Abou-Nahia, M, Al-Badriyeh, D, Abushanab, D, Abu-Ghalwa, M, Mansour, A, Kurdi, B, Al Rifai, H
Format: Article
Language:English
Subjects:
FDA approval
Lung diseases
Newborn babies
Premature babies
Pulmonary arteries
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Summary:BackgroundBronchopulmonary dysplasia (BPD) is associated with poor long-term neurodevelopmental outcomes and an increased readmission risk because of respiratory conditions. Since the 2005 FDA approval of sildenafil for adults with pulmonary artery hypertension, and despite a 2012 black box warning against long-term use in 1–7 years’ old children due to increased risk of death at high doses, there has been an increasing trend of utilising the off-label preparation of sildenafil in infants.PurposeA proof-of-concept randomised double-blind pilot study was conducted to investigate the use of sildenafil in preventing BPD in preterm infants.Material and methodsThe pilot trial was conducted in the neonatal intensive care unit of the Women’s Wellness and Research Center. Infants with a gestational age of 240/7–296/7 weeks were eligible if they needed respiratory or oxygen support greater than or equal to 25%, and if they were at postnatal age of
ISSN:2047-9956
2047-9964
DOI:10.1136/ejhpharm-2019-eahpconf.610