A single-dose indomethacin prophylaxis for reducing perinatal brain injury in extremely low birth weight infants: a non-inferiority analysis

Objectiveto evaluate whether rates of perinatal brain injury among extremely low birth weight infants are comparable between two treatments: single-dose indomethacin prophylaxis (sgl-ip) (0.2 mg/kg, given once) vs. standard-dose indomethacin prophylaxis (std-ip) (0.1 mg/kg/day, 3 days).methodsin this retrospective study, the primary outcome was perinatal brain injury (neuro-imaging evidence of intraventricular hemorrhage or periventricular leukomalacia) or death before discharge. a non-inferior efficacy of an sgl-ip regimen compared with a std-ip regimen was determined by calculating the adjusted difference in the risk of the primary outcome using a multivariable logistic regression model. a 10-percentage point non-inferiority margin was favored.resultsprevalence rates of primary outcome were 41.7% in the sgl-ip group (n = 403) and 42.5% in the std-ip group (n = 509) (adjusted risk difference: −1.2, 95% ci: −7.6 to +5.2, p = 0.71).conclusionuse of a single prophylactic indomethacin dose was as effective as a standard regimen in preventing perinatal brain injury.