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

Afif EL-Khuffash; Patrick J McNamara; Colm Breatnach; Neidin Bussmann; Aisling Smith; Oliver Feeney; Elizabeth Tully; Joanna Griffin; Willem P de Boode; Brian Cleary; Orla Franklin; Eugene M Dempsey

doi:10.1186/s40748-018-0093-1

Back

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

Journal article

Open access

Peer reviewed

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

Afif EL-Khuffash, Patrick J McNamara, Colm Breatnach, Neidin Bussmann, Aisling Smith, Oliver Feeney, Elizabeth Tully, Joanna Griffin, Willem P de Boode, Brian Cleary, …

Maternal health, neonatology and perinatology, Vol.4, 24

12/03/2018

DOI: 10.1186/s40748-018-0093-1

PMCID: PMC6276183

PMID: 30524749

Files and links (1)

url

https://doi.org/10.1186/s40748-018-0093-1View

Published (Version of record) Open Access

Abstract

Persistent 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.

Neonates

Nitric oxide

Milrinone

Pulmonary hypertension

Phosphodiesterase

Details

Title: Subtitle: 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
Creators: Afif EL-Khuffash
Patrick J McNamara
Colm Breatnach
Neidin Bussmann
Aisling Smith
Oliver Feeney
Elizabeth Tully
Joanna Griffin
Willem P de Boode
Brian Cleary
Orla Franklin
Eugene M Dempsey
Resource Type: Journal article
Publication Details: Maternal health, neonatology and perinatology, Vol.4, 24
DOI: 10.1186/s40748-018-0093-1
PMID: 30524749
PMCID: PMC6276183
NLM abbreviation: Matern Health Neonatol Perinatol
ISSN: 2054-958X
Publisher: BMC
Grant note: name: Health Research Board Ireland, award: CTN-PP-2014-872
Language: English
Date published: 12/03/2018
Academic Unit: Stead Family Department of Pediatrics; Neonatology; Internal Medicine
Record Identifier: 9984093602202771

Metrics

21 Record Views