NCT03506841

Cerebrolysin and Neurodevelopment in Preterm Infants

Efficacy and Safety of Cerebrolysin on Neurodevelopmental Outcome of Preterm Infants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mansoura University Children Hospital · Academic / Other
• Sex: All
• Age: 5 Months – 1 Year
• Healthy volunteers: Not accepted

Summary

The overall aim of the study is to assess the effect of Cerebrolysin on physical and mental development of preterm infants by Denver Scale II at different ages of 5, 7 and 12 months

Detailed description

There is an inverse relationship between birth weight or gestational age and risk for developmental impairment, with increasing incidence as birth weight or gestational age decreases. Serious impairment, defined as problems in body function or structure which may be temporary or permanent, is generally a more stable condition and typically leads to a disability requiring rehabilitation. Mild impairment is a more reversible condition amenable to early intervention. Studies that have followed extremely preterm and extremely low birth weight infants into school age and early adulthood have shown higher rates of motor, cognitive or behavioral impairments as compared with infants born at term. The neurologic consequences of extreme prematurity range from mild behavioral and cognitive defects to severe disability. Perinatal neuroprotection aims to reduce these outcomes. Cerebrolysin is a porcine brain-derived peptide preparation that acts like endogenous neurotrophic factors. It is produced by a standardized enzymatic breakdown of lipid-free brain protein powder and consists of low molecular weight peptides and free amino acids. The pharmacodynamic effects of Cerebrolysin can be categorized in terms of neuronal survival (e.g. trophic and survival promoting actions), neuroprotection (e.g. limiting neuronal dysfunction, especially in adverse conditions), neuroplasticity (e.g. adaptive responses to changing conditions) and neurogenesis (e.g. promoting differentiation of progenitor cells). We aim to assess the effect of Cerebrolysin on physical and mental development of preterm infants at different ages of life at 5, 7 and 12 months.

Conditions

• Infant Development
• Cerebral Palsy
• Preterm Infant

Interventions

Type	Name	Description
DRUG	Cerebrolysin	Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections).

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2018-04-24
• Last updated: 2021-03-15

Locations

1 site across 1 country: Egypt