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Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial

BACKGROUND: The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation. OBJECTIVES: The current study aimed to investigate the efficacy of oral sildenafil and...

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Autores principales: El-Ghandour, Mamdouh, Hammad, Bahaa, Ghanem, Mohamed, Antonios, Manal A. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453074/
https://www.ncbi.nlm.nih.gov/pubmed/32856285
http://dx.doi.org/10.1007/s40272-020-00412-4
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author El-Ghandour, Mamdouh
Hammad, Bahaa
Ghanem, Mohamed
Antonios, Manal A. M.
author_facet El-Ghandour, Mamdouh
Hammad, Bahaa
Ghanem, Mohamed
Antonios, Manal A. M.
author_sort El-Ghandour, Mamdouh
collection PubMed
description BACKGROUND: The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation. OBJECTIVES: The current study aimed to investigate the efficacy of oral sildenafil and intravenous milrinone infusion and compare the effects of these drugs in combination versus as monotherapy in neonates with PPHN. METHODS: A double-blind randomized controlled trial was conducted in which neonates with PPHN were divided into three groups of 20 patients each: group 1 received oral sildenafil starting at 0.5 mg/kg every 6 h to a target maintenance dose of 2 mg/kg every 6 h; group 2 received intravenous milrinone 0.5 μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone. RESULTS: Post-treatment pulmonary artery systolic pressure was significantly lower in group 3 than in groups 1 and 2, which both received monotherapy (p = 0.031). The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups. Combined use of both drugs demonstrated a beneficial synergistic effect with better outcomes and reduced mortality. CONCLUSION: Dual therapy using sildenafil and milrinone was superior to monotherapy with either drug in neonates with severe PPHN and is recommended for use in resource-constrained settings. REGISTRATION: Pan African Clinical Trial Registry identifier number PACTR201902691230243.
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spelling pubmed-74530742020-08-28 Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial El-Ghandour, Mamdouh Hammad, Bahaa Ghanem, Mohamed Antonios, Manal A. M. Paediatr Drugs Original Research Article BACKGROUND: The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation. OBJECTIVES: The current study aimed to investigate the efficacy of oral sildenafil and intravenous milrinone infusion and compare the effects of these drugs in combination versus as monotherapy in neonates with PPHN. METHODS: A double-blind randomized controlled trial was conducted in which neonates with PPHN were divided into three groups of 20 patients each: group 1 received oral sildenafil starting at 0.5 mg/kg every 6 h to a target maintenance dose of 2 mg/kg every 6 h; group 2 received intravenous milrinone 0.5 μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone. RESULTS: Post-treatment pulmonary artery systolic pressure was significantly lower in group 3 than in groups 1 and 2, which both received monotherapy (p = 0.031). The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups. Combined use of both drugs demonstrated a beneficial synergistic effect with better outcomes and reduced mortality. CONCLUSION: Dual therapy using sildenafil and milrinone was superior to monotherapy with either drug in neonates with severe PPHN and is recommended for use in resource-constrained settings. REGISTRATION: Pan African Clinical Trial Registry identifier number PACTR201902691230243. Springer International Publishing 2020-08-28 2020 /pmc/articles/PMC7453074/ /pubmed/32856285 http://dx.doi.org/10.1007/s40272-020-00412-4 Text en © Springer Nature Switzerland AG 2020 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Original Research Article
El-Ghandour, Mamdouh
Hammad, Bahaa
Ghanem, Mohamed
Antonios, Manal A. M.
Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial
title Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial
title_full Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial
title_fullStr Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial
title_full_unstemmed Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial
title_short Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial
title_sort efficacy of milrinone plus sildenafil in the treatment of neonates with persistent pulmonary hypertension in resource-limited settings: results of a randomized, double-blind trial
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453074/
https://www.ncbi.nlm.nih.gov/pubmed/32856285
http://dx.doi.org/10.1007/s40272-020-00412-4
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