PD Dr Heike Rabe, Director of Research at the Department of Neonatalology, Brighton & Sussex University Hospital has produced a video presentation of one of her recent research projects which shows how premature babies benefit from extra placental blood.
The project, which included feedback from parents, showed a range of benefits including better neuro-developmental outcomes, reduced bowel complications, a requirement for fewer medications, reduced transfusion need/risk, increased iron stores and a reduction in the rate of bleeding on the brain.
Dr Rabe, is the Coordinator for the Neocirculation Consortium (NeoCirc) project which seeks to produce safety and efficacy data on the use of Dobutamine in the treatments of hypotension in pre-term babies. 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.
NeoCirc includes international experts in neonatal medicine, pharmacology, pharmacogenomics, drug formulation and pre-clinical neonatal models and an experienced group of experienced multicentre clinical trials Neonatal Intesnive Care Units (NICU’s). The 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. NeoCirc 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.Onorach are a partner organization within the NeoCirc consortium and have been involved in monitor management and training with the aim of ensuring the quality of the groups data meets GCP standards. Onorach will also contribute to document design and full study management across all the EU sites going forward.
Click HERE to view the video
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