NEO-CIRC Gets EMA Green Light


Hypotension is a significant global problem and is associated with brain injury in preterm babies; if this can be managed, this will result in a reduction both in brain injury and poor neurodevelopment outcomes.
To improve neonatal care and outcome for preterm babies, a consortium was set up, headed by Prof Heike Rabe from Brighton and Sussex University Hospitals NHS Trust. The project is titled the NEO-CIRC project (Dobutamine for NEOnatal CIRCulatory failure defined by novel biomarkers project).


The NEO-CIRC project has been running since October 2011, with the aim of developing and studying an age appropriate formulation of Dobutamine for new-born babies and to develop a new definition of neonatal shock. This project has the potential to significantly improve the health of future generations. The pharmaceutical, pre-clinical and clinical work continues in order to achieve a Paediatric Use Marketing Authorisation (PUMA) for dobutamine. If a PUMA for Dobutamine can be achieved, this will contribute to the development of an efficient healthcare system with relevant short-term and long-term health care savings.

Changes imposed by the European Medicine Agency (EMA) on the agreed Paediatric Investigational Plan (this is a plan specifically for development of medicines in children) meant that both a PUMA and PIP needed to be agreed before the study could start. In 2012, work began on devising 3 trials for the project. After the first study was completed in April 2016, and after deciding a change in trial strategy and clinical approach, a request of the PIP modification (RfM) was submitted and accepted by the EMA Paediatric Committee (PDCO). A further RfM was submitted in February 2017 and the consortium is delighted to announce that the new clinical trial can proceed, after it was granted approval by the EMA. This means that the NEO-CIRC project remains on track to obtain regulatory authorisation for Dobutamine (the second most widely used drug for neonatal shock) and to propose an agreement for a new definition of neonatal shock.   

As a consortium member, Onorach is actively supporting the set-up and management of the International sites for the new study. This includes monitoring, documentation management, training, communication, clinical expertise and adequate study support to ensure the NEO-CIRC consortium can ensure that the clinical safety and efficacy of the study is maintained until study end.

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