Comparative evaluation of effectiveness and safety of meropenem in term and preterm neonates with neonatal sepsis

Abstract

Background: Neonatal sepsis is one of the most common causes of substantial neonatal morbidity and mortality. In India, it is estimated that 7.5 lakh neonates die every year, which is the highest neonatal mortality rate (NMR) in the world. This is despite the fact that NMR declined from 44/1000 lives birth in 2000–28/1000 live births in 2013. The rate of decline has been slow and lags behind that of the infant mortality rate and the under-five mortality rate. Aims and Objectives: To study the effectiveness and safety of meropenem in the treatment of sepsis affecting term and preterm neonates. Materials and Methods: The study was a prospective, observational study conducted at Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. A total of 76 subjects were enrolled (38 term and 38 preterm neonates). All neonates, preterm or term, admitted to the Neonatal Intensive Care Unit with neonatal sepsis, either clinical or culture-proven sepsis, who had not received meropenem before admission and would be given meropenem as empirical or culture-sensitive were included. All enrolled neonates were evaluated for the effectiveness of meropenem. Pre- and post-meropenem dose clinical and laboratory data were evaluated using the presumptive clinical cure score (PCCS). Results: There was a significant difference between pre- and post-PCCS of all the neonates (P < 0.001) in both groups. There was no significant difference in the effectiveness of meropenem therapy in neonatal sepsis in term and preterm neonates (P = 0.253). There was no significant difference in the adverse reaction profile between preterm and term neonates for skin rash (P = 0.614) and diarrhea (P = 1.00). Conclusion: Meropenem is quite effective and safe for neonatal sepsis in both term and preterm neonates. So, giving meropenem as a second or third line in a dose of 20–40 mg/kg 8 hours a day according to gestation is a good drug for the treatment of neonatal sepsis.