Safety and Efcacy of Cerebrolysin in Infants with Communication Defects due to Severe Perinatal Brain Insult: A Randomized Controlled Clinical Trial

Background and Purpose Te neuroregenerative drug Cerebrolysin has demonstrated efcacy in improving cognition in adults with stroke and Alzheimer’s disease. Te aim of this study was to determine the efcacy and safety of Cerebrolysin in the treatment of communication defects in infants with severe perinatal brain insult. Methods A randomized placebo-controlled clinical trial was conducted in which 158 infants (age 6–21 months) with communication defects due to severe perinatal brain insult were enrolled; 120 infants completed the study. The Cerebrolysin group (n=60) received twice-weekly Cerebrolysin injections of 0.1 mL/kg body weight for 5 weeks (total of ten injections). Te placebo group (n=60) received the same amount and number of normal saline injections. Results Te baseline Communication and Symbolic-Behavior-Scale-Developmental Profle scores were comparable between the two groups. Afer 3 months, the placebo group exhibited improvements in the social (p