HIP Trial

Assuming an annual birth rate of 10.25births/1,000 population approximately 25,000 Extremely Low Gestational Age Newborns are born every year in the EU. Conservative figures estimate that approximately hals of all these babies will develop low blood pressure and require treatment. However, no uniform criteria exist to define hypotension and the evidence to support our current management strategies is limited. Many of these interventions have been deerived from adult literature and have not been validated in the newborn. Dopamine remains the most common inotrope used despite little evidence that it improves outcome. Hypotension is not only associated with mortality of preterm infants but also associated with brain injury and impaired neurosensory development in ELGAN survivors. Preterm brain injury has far reaching implications for the child, parents, family, health service and society at large. It is therefore essential that we now design and perform the appropriate trials to determine whether the infusion of inotropic agents is associated with improved outcome. We have assembled a consortium with expertise in key areas of neonatal cardiology, neonatology, neurophysiology, basic science and pharmacology with the intention of answering these questions. The objectives of the group are as follow: 1. To perform a multinational, randomized controlled trial to evaluate whether a more restricted approach to the diagnosis and management of hypotension compared to a standard approach, with epinephrine or dopamine as a first line inotrope, affects survival without significant brain injury at 36 weeks gestational age in infants bron less than 28 weeks gestation and affects survival without neurodevelopmental disability at 2 years corrected age. 2. To perform pharmacokinetic and pharmacodynamic studies of both epinephrine and dopamine. 3. To develop and adapt a formulation of both agents suitable for newborns in order to apply for a Paediatric Use Marketing Authorization.

Trefwoorden:Extremely Low Gestational Age Newborns, Dopamine, Epinephrine, Hypotension, Controlled, Clinical trial, Randomized, EEG, PUMA, Multinational, Preterm newborn, NIRS, Blood pressure, ELGAN, Inotrope