The Project

Background

Dobutamine is a drug currently used off label, in the treatment of systemic abnormally low blood pressure (hypotension) in both pre term and full term babies. Sustained hypotension may, and impaired organ perfusion will, cause brain injury and poor neurodevelopmental outcomes. Currently, no uniform criteria exist to define hypotension and there is little evidence to support current intervention strategies, which vary widely. Recently, superior vena cava (SVC) flow has been proposed as a more reliable indicator of circulatory failure than low blood pressure and preliminary results suggest Dobutamine is the optimum therapeutic in such cases.

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Neocirculation

The Neocirculation project will conduct trials to provide safety and efficacy data for Dobutamine as a first line inotrope for all gestational ages. Pre-clinical; pharmacokinetic; pharmacodynamic; metabolomic and pharmacogenomic studies will also be conducted to build a strong the understanding of the mode of action of Dobutamine. The Neocirculation consortium will also develop improved biomarkers of hypotension- with a focus on SVC flow, and develop and adapt a formulation of Dobutamine suitable for newborns and finally apply for a Paediatric Use Marketing Authorisation (PUMA) which will cover the indication and appropriate formulation for the paediatric population.

The Neocirculation consortium includes international experts in neonatal medicine, pharmacology, pharmacogenomics, drug formulation and pre-clinical neonatal models and an experienced group of experienced multicentre clinical trials NICU’s.

Outcomes anticipated include improved biomarkers of organ perfusion; a new consensus definition of neonatal circulatory failure and answers to key clinical practice uncertainties, including variability of response to Dobutamine in common pathophysiologies seen in newborn infants impact on longer term developmental outcomes so important to the patients, families and wider society.