THE HIP TRIAL

Management of Hypotension In the Preterm Extremely Low Gestational Age Newborn

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 Obiettivo del progetto (Objective)

'Assuming an annual birth rate of 10.25 births/1,000 population approximately 25,000 Extremely Low Gestational Age Newborns are born every year in the EU. Conservative figures estimate that approximately half 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 derived 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 is 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 follows: 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 dopamine as a first line inotrope, affects survival without significant brain injury at 36 weeks gestational age in infants born less than 28 weeks gestation and affects survival without neurodevelopmental disability at 2 years corrected age 2. To perform pharmacokinetic and pharmcodynamic studies of dopamine 3. To develop and adapt a formulation of dopamine suitable for newborns in order to apply for a Paediatric Use Marketing Authorization'

Descrizione progetto (Article)

Hypotension is considered to be responsible for inadequate oxygen delivery to the organs, leading to impaired cerebral blood flow, cerebral ischaemia and brain injury. Although there are no clear criteria on the definition and long-term impact of hypotension, current clinical management entails treatment for this pathology with inotropic drugs (e.g.dopamine). However, preterm infants treated for low blood pressure often show no signs of shock and may have normal systemic blood flow.

Members of the EU-funded 'Management of hypotension in the preterm extremely low gestational age newborn' (http://www.hip-trial.com (THE HIP TRIAL)) project propose to address this issue through a more observational approach without intervention. Retrospective analysis of a large neonatal database (CNN) has demonstrated that treatment of hypotension and not hypotension itself was associated with brain injury.

Given that current management measures are based on evidence from small studies, THE HIP TRIAL project is conducting a phase III randomised trial in order to evaluate the impact of dopamine for hypotension treatment. Clinical trial preparations are ongoing with considerable effort being devoted to finalising the actual protocol, Informed Consent Form and Parent Information leaflet.

A pan-European survey intended to collect information on current diagnosis and treatment practices has been completed. To advance existing practices and train clinical personnel, a series of training sessions and workshops have been planned and taken place. They focused on echocardiography, near-infrared spectroscopy and electroencephalography as means of diagnosis and of assessing blood pressure, cerebral activity and cardiovascular performance in preterm infants. Expert groups in these methodologies have been established and will be used during the clinical trial.

THE HIP TRIAL is the largest study conducted so far to address the impact of inotropic drug administration for treating hypotension in preterm infants. Since brain injury leads to lifelong disability, the outcome of the study holds great socioeconomic implications.