Pyritinol for post asphyxial encephalopathy in term babies-- a randomized double-blind controlled trial.

OBJECTIVE To evaluate the efficacy of pyritinol in improving the neurodevelopmental outcome at one year of age among term babies with post-asphyxial encephalopathy. SETTING Level II Neonatal Nursery and Child Development Centre, Medical College, Thiruvananthapuram. DESIGN Randomised placebo controlled double blind trial. PARTICIPANTS 108 term babies with post-asphyxial encephalopathy, stratified into three grades based on clinical criteria. INTERVENTION The treatment group (n=54) received pyritinol and the control group (n=54) received placebo, in exactly the same increasing dosage schedule of 1 to 5 mL liquid drug (20-100 mg) from 8th postnatal day until the end of six months. OUTCOME VARIABLES Mean Mental Development Index (MDI) and mean Psychomotor Development Index (PDI) measured on Bayley Scales of Infant Development at one year of age. RESULTS No statistically significant difference was observed in MDI or PDI scores at one year between the treatment and control groups. The confidence interval for the differences ranged from -6.3 to 8.7 for MDI and from - 4.1 to 12.7 for PDI. On multiple regression analysis using one year MDI and PDI scores, even after controlling for birthweight, there was no statistically significant difference between the treatment and control groups. CONCLUSION Pyritinol is not useful in improving the neurodevelopmental status of babies with post-asphyxial encephalopathy at one year of age.