The use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1): study protocol and review of literature

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dc.contributor.authorEl-Khuffash, Afif
dc.contributor.authorMcNamara, Patrick J.
dc.contributor.authorBreatnach, Colm
dc.contributor.authorBussmann, Neidin
dc.contributor.authorSmith, Aisling
dc.contributor.authorFeeney, Oliver
dc.contributor.authorTully, Elizabeth
dc.contributor.authorGriffin, Joanna
dc.contributor.authorde Boode, Willem P.
dc.contributor.authorCleary, Brian
dc.contributor.authorFranklin, Orla
dc.contributor.authorDempsey, Eugene M.
dc.contributor.funderHealth Research Boarden
dc.date.accessioned2019-06-24T13:29:18Z
dc.date.available2019-06-24T13:29:18Z
dc.date.issued2018-12-03
dc.description.abstractPersistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition which results in a mortality of up to 33%. Up to 40% of infants treated with nitric oxide (iNO) either have a transient response or fail to demonstrate an improvement in oxygenation. Milrinone, a selective phosphodiesterase 3 (PDE3) inhibitor with inotropic and lusitropic properties may have potential benefit in PPHN. This pilot study was developed to assess the impact of milrinone administration on time spent on iNO in infants with PPHN. This is a multicentre, randomized, double-blind, two arm pilot study, with a balanced (1:1) allocation of 20 infants. In this pilot study, we hypothesise that infants ≥34 weeks gestation and ≥ 2000 g with a clinical and echocardiography diagnosis of PPHN, intravenous milrinone used in conjunction with iNO will result in a reduction in the time spent on iNO. In addition, we hypothesise that milrinone treatment will lead to an improvement in myocardial performance and global hemodynamics when compared to iNO alone. We will also compare the rate of adverse events associated with the milrinone, and the pre-discharge outcomes of both groups. The purpose of this pilot study is to assess the feasibility of performing the trial and to obtain preliminary data to calculate a sample size for a definitive multi-centre trial of milrinone therapy in PPHN.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid24en
dc.identifier.citationAfif, E.K., McNamara, P.J., Breatnach, C., Bussmann, N., Smith, A., Feeney, O., Tully, E., Griffin, J., de Boode, W.P., Cleary, B. and Franklin, O., 2018. The use of milrinone in neonates with persistent pulmonary hypertension of the newborn-a randomised controlled trial pilot study (MINT 1): study protocol and review of literature. Maternal health, neonatology and perinatology, 4(1): 24 (12pp) DOI: 10.1186/s40748-018-0093-1en
dc.identifier.doi10.1186/s40748-018-0093-1en
dc.identifier.endpage12en
dc.identifier.issn2054-958X
dc.identifier.issued1en
dc.identifier.journaltitleMaternal Health, Neonatology and Perinatologyen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/8099
dc.identifier.volume4en
dc.language.isoenen
dc.publisherBMCen
dc.relation.urihttps://mhnpjournal.biomedcentral.com/articles/10.1186/s40748-018-0093-1
dc.rights© 2018 The Author(s)en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectNitric oxideen
dc.subjectPulmonary hypertensionen
dc.subjectMilrinoneen
dc.subjectPhosphodiesteraseen
dc.subjectNeonatesen
dc.titleThe use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1): study protocol and review of literatureen
dc.typeArticle (peer-reviewed)en
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