Abstract: BACKGROUND: A significant proportion of preterm infants experience developmental delay despite receiving a post discharge early interventional care. Cerebrolysin is a peptide mixture which acts similar to endogenous neurotrophic factors through promoting neurogenesis and enhancing neuronal plasticity. OBJECTIVE: To compare the effect of Cerebrolysin plus routine intervention program versus routine intervention program alone on the outcome of preterm infants at high risk for neurodevelopmental delay. METHODS: In a randomized controlled trial, high-risk preterm infants < 32 weeks’ gestation who have abnormal neurological assessment at two months corrected post-natal age were randomized at 6 months corrected post natal age to receive either early intervention program or early intervention program plus Cerebrolysin injection of 0.1 mL/kg body weight every week for 3 months as an adjuvant therapy. The primary outcome was the rate of failure of the gross motor assessment at 12 months of corrected age and secondary outcomes included fine motor, language, and personal social development at 12 months corrected post-natal age as assessed by Denver Developmental Screening Test II. RESULTS: Cerebrolysin group had a significant lower number of infants diagnosed with failed gross motor development compared to infants in the routine intervention group [10 (33%) versus 21 (70%), p = 0.009]. Cerebrolysin group had a significant lower number of infants diagnosed with failed fine motor, language and personal social development compared to infants in the routine intervention group. CONCLUSION: Cerebrolysin, as an adjuvant therapy to routine early interventional care, may improve gross motor development of high-risk preterm infants at 12 months corrected post-natal age.