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المؤلفAbounahia, Fouad F
المؤلفAbu-Jarir, Rawia
المؤلفAbounahia, Mohamed F
المؤلفAl-Badriyeh, Daoud
المؤلفAbushanab, Dina
المؤلفAbu-Ghalwa, Mahmoud
المؤلفMansour, Ashraf
المؤلفKurdi, Bader
المؤلفAl-Rifai, Hilal
تاريخ الإتاحة2019-09-08T08:48:24Z
تاريخ النشر2019-08-01
اسم المنشورClinical Drug Investigation
المعرّفhttp://dx.doi.org/10.1007/s40261-019-00834-0
الاقتباسAbounahia, F.F., Abu-Jarir, R., Abounahia, M.F. et al. Clin Drug Investig (2019). https://doi.org/10.1007/s40261-019-00834-0
الرقم المعياري الدولي للكتاب1173-2563
معرّف المصادر الموحدhttp://hdl.handle.net/10576/11791
الملخصBronchopulmonary dysplasia (BPD) is the need for oxygen therapy at 36 weeks postmenstrual age (PMA). Sildenafil has been shown to enhance the lung alveolarization and vascularization in newborn animal models after lung injury and has possible therapeutic potential for the prevention of BPD. To perform a proof-of-concept, Phase II, pilot randomized, double-blind, clinical trial to study the efficacy of sildenafil in preventing BPD, in postnatal (< 24 h), extremely and very preterm infants. This Phase II, pilot randomized, double-blind, clinical trial was conducted in the Neonatal Intensive Care Unit of Women's Wellness and Research Center, Doha, Qatar during 2012-2014. Infants of 24-29 weeks' gestation were eligible if they needed respiratory or oxygen support ≥ 25% at randomization, and if they were at a postnatal age of < 24 h at randomization. Forty preterm infants were randomly assigned to receive off-label oral sildenafil (0.5 mg/kg every 6 h) or a placebo solution, for one week. The primary endpoints were the incidence of BPD and death at 36 weeks PMA, and the side effects. Secondary outcomes included the incidence of BPD and the respiratory support at day 28 of life, duration of oxygen use, fraction of inspired oxygen use at 36 weeks and 28 days of life, duration of hospitalization, and the incidence of significant retinopathy of prematurity, severe intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, patent ductus arteriosus, and late sepsis. No significant differences were observed between the sildenafil and placebo study groups in mortality at 36 weeks PMA (10% vs 20%, p = 1), respiratory support at 36 weeks (30% vs 25%, p = 0.57), and side effects (0% vs 0%). For all other secondary outcomes, no significant differences were detected. While not associated with side effects, off-label oral sildenafil did not demonstrate benefits in the prevention of BPD or death in the extreme and very preterm infants. Future studies of dosing and efficacy that target different regimens of sildenafil are warranted before sildenafil is recommended for the prevention of BPD.
راعي المشروعThe study was supported by Medical Research Center, Hamad Medical Corporation [Grant number RP#11087/11].
اللغةen
الناشرSpringer Verlag
الموضوعSildenafil
Bronchopulmonary dysplasia
العنوانProphylactic Sildenafil in Preterm Infants at Risk of Bronchopulmonary Dysplasia: A Pilot Randomized, Double-Blinded, Placebo-Controlled Trial.
النوعArticle
الصفحات1–15
ESSN1179-1918


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