Dr Beau Batton and colleagues from the NICHD network have just published a paper detailing their attempt, and failure, to design a trial of early hypotension treatment. The design looks fine on paper, but when they tried to do the trial there were numerous road blocks. One arm of the trial included hydrocortisone, so babies receiving prophylactic indomethacin were excluded, which was a practice that changed after design of the study. There were fewer hypotensive babies than expected. But even of the eligible babies, only 17% were enrolled.
Establishing equipoise will be a major problem in doing trials, but it is very important that we answer the questions about how to treat hypotension in extremely preterm infants.
The link on the side bar to the HIP trial will take you to the website for our trial, which will be starting soon, which will try and answer the question ‘among infants less than 28 weeks gestation who have a low blood pressure and good clinical perfusion in the first 3 days of life, does treatment with dopamine compared to placebo improve the chances of surviving to 36 weeks without a serious brain injury?’
Batton BJ, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Van Meurs KP, Carlo WA et al: Feasibility Study of Early Blood Pressure Management in Extremely Preterm Infants. J Pediatr 2012(epub before print).http://www.sciencedirect.com/science/article/pii/S0022347612000339
Vain NE, Barrington KJ: Feasibility of Evaluating Treatment of Early Hypotension in Extremely Low Birth Weight Infants. J Pediatr 2012(epub before print).http://www.sciencedirect.com/science/article/pii/S0022347612002326