BrePco Biopharma announce the presentation of selected results of late-stage clinical trial in extremely premature neonates

June 12, 2019 by admin

Dublin, Ireland – June 11, 2019. BrePco Biopharma (affiliate of BCO Pharma) announces selected data from its phase-III clinical trial were presented at the Pediatric Academic Societies annual meeting held recently in Baltimore, MD. The analysis demonstrated, conclusively for the first time, that impaired cerebral autoregulation—essentially the inability to maintain consistent blood pressure within the brain—increases the risk for a type of brain injury called intraventricular hemorrhage (IVH) in very premature babies.

The data, were part of a sub-group analysis of the ”Hypotension in Premature Neonates” or “HIP” trial—of which BrePco is the sponsor. The research team monitored brain oxygenation and blood pressure continuously during the first three days of life for a group of 89 extremely premature babies. They found that hypotension, impaired cerebral autoregulation and reduced cerebral blood flow all increased the risk for IVH and mortality. This is particularly the case during the first 12 to 24 hours of life. The study also demonstrated that dopamine raises blood pressure in very premature, hypotensive neonates.

The role of cerebral autoregulatory capacity in IVH had been observed previously, but this study demonstrates the connection conclusively for the first time. This will help researchers better understand the how the injuries occur and will help physicians more effectively care for extremely premature newborns.

About the HIP Consortium

The HIP Trial is being conducted by a consortium of 13 institutions, mostly university hospitals, from six EU member states and Canada. The group includes leading researchers in the fields of neonatology, neurophysiology, cardiology and pharmacology. The group’s objective is to develop a more effective treatment for hypotension in premature infants than is currently available.BrePco Biopharma is a member of the HIP consortium and is the commercial sponsor of the program. The HIP trial was funded in part by a European Union FP7 grant.

Intraventricular ventricular hemorrhage in premature babies

Survival of the most immature infants has increased significantly over the last three decades, especially among the most immature and smallest babies. The improved survival rate has brought the increased challenge of treating conditions that are unique to very premature babies. Intraventricular ventricular hemorrhage (IVH) which is one such condition, involves a rupture, not caused by trauma, of the (very delicate) vasculature in the brain. In severe cases the injury may result in neurodevelopment delays.

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