Adverse Effects of Topiramate in Neonate with Moderate to Severe Perinatal Asphyxia: A Randomized Controlled Trial

Abstract

Introduction: A harmful pregnancy condition that harms both the mother and the fetus is perinatal asphyxia. It frequently happens as a result of challenges during labour, including protracted or challenging delivery, concerns with the umbilical cord, placental abnormalities, or maternal health conditions. Topiramate, an anticonvulsant, works through a variety of different methods. Topiramate looks to be effective as a neuroprotective agent as well as an anti-seizure medication in animal models of newborn brain injury. Angiogenesis, neurogenesis, and neuronal anti-apoptotic pathways are all stimulated and regulated by topiramate. In light of this, this observational study was conducted to ascertain Topiramate's negative consequences in kids with mild to moderate neonatal hypoxia. Methods: This observational case-control study was carried out in the Neonatal ward and ICU of Dhaka Shishu Hospital from April 2015 to March 2016. A total of 64 neonates were enrolled in this study and were assigned Group A -the interventional group (n=32) received topiramate and standard treatment protocol, and Group B or the control group (n=32) received only standard treatment protocol. The data were analyzed according to standard procedure. Results: Among the study neonates, based on sex in case and control groups, respectively, seventeen (17,53%) and twenty-one (21,66%) neonates were male, and fifteen (15,47%) and eleven (11,44%) neonates were female. Statistically, the sex distribution between groups was not significant (p=0.44). USG finding of the neonates after treatment was normal in 12 (48%) and 13(41%), and abnormal in 20(32%) and 19 (59%) neonates in the control and case groups, respectively. Out of 27 neonates in the control group, 11 (41%) were neurologically normal, and 16 (59%) had abnormal neurological findings. Out of 29 neonates in the case group, 24 (73%) were neurologically normal, and 5(17%) showed abnormal neurological findings. Statistically, significant variation ..