MINT – The use of Milrinone in neonates with persistent pulmonary hypertension of the newborn.
Principal investigator- Afif El- Khuffash (Rotunda Maternity Hospital)
Persistant pulmonary hypertension (PPHN) is a relatively common condition occurring in 0.5-7 per 1000 live births and results in mortality ranging between 4%-33%. Inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO) are the only current therapeutic options that have been systemically evaluated in clinical trial. The widespread use of iNO has resulted in a reduction in the need for ECMO however mortality and long-term morbidity remain unchanged. In addition, up to 40% of infants treated with iNO either has transient response or fail to demonstrate an improvement in oxygenation. There is a lack of consensus regarding alternative therapies in the setting of PPHN when there is a slow or lack of response to iNO.
The use of milirinone (a cardiac medication) in the setting of PPHN is limited to case series demonstrating an improvement in oxygenation when used in infants failing to respond to iNO. Its inotropic and vasodilator properties make it ideal agent to use and may improve response to therapy and reduce mortality associated with the disease.
The purpose of the pilot study is to assess the feasibility of performing a pivotal trial to obtain preliminary data to calculate a sample size for definitive multicentre trial of milrinone therapy in PPHN. We aim to recruit a total of 30 infants of a period of 1 year.
We hypothesis that infants > 34 weeks gestation with PPHN, intravenous milrinone used in conjunction with iNO will result in a reduction in the time spent on iNO and invasive ventilation and that milrinone treatment will lead to an improvement in myocardial performance and global hemodynamics when compared to iNO alone.