Revisiting infant hypotension
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' (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.
Keywords
Preterm infant, hypotension, dopamine, clinical trial, brain injury
