Trial Complete



management of Hypotension In the Preterm extremely low gestational age newborn


Principal Investigator – Dr. David Corcoran

Hypotension remains a significant problem in the preterm infant and is statistically associated with adverse short-term and long-term outcomes. Currently no uniform criteria exist to define hypotension and the evidence to support our current management strategies is limited. HIP stands for: Management of Hypotension In the Preterm Extremely Low Gestational Age Newborn. The HIP Trial is an EU FP7 funded project that will be the largest multicentered European study in Extremely Low Gestational Age Newborns (ELGANs).

The aim of the HIP Trial is to develop an effective treatment of hypotension in the extremely low gestational age newborn. Hypotension cannot only lead to mortality of preterm infants but also to brain injury and impaired neurosensory development. Preterm brain injury has far reaching implications and makes it necessary to perform an appropriate trial to determine whether the infusion of inotropic agents leads to improved outcome.

Short-term clinical outcomes will be closely monitored. The efficacy and safety of each treatment will be rigorously assessed. This will include objective assessment of cardiac output with echocardiography, cerebral oxygenation with NIRS and continuous EEG as an indirect measure of cerebral activity. The protocol includes neurodevelopmental follow-up of the cohort of babies at 12 and 24 months. This is one of the strengths of the study and will provide accurate data on the long-term safety of dopamine in Extremely Low Birth Weights (<1000g) (ELBW). This data does not exist and is urgently needed.