Cerebrolysin and Neurodevelopment in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT03506841|
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : March 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Infant Development Cerebral Palsy Preterm Infant||Drug: Cerebrolysin||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Cerebrolysin on Neurodevelopmental Outcome of Preterm Infants|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
Active Comparator: Cerbrolysin
Preterm infants with gestational age less than 32 weeks at birth will receive once weekly Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections) starting at the corrected postnatal age of 5 months.
Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections).
No Intervention: Control
Preterm infants with gestational age less than 32 weeks at birth will receive routine care.
- Neurodevelopmental outcome [ Time Frame: 9 months ]Assessment of the physical and mental functions of preterm infant by Denver Developmental Screening Test II (DDST II)
- Side effects of cerebrolysin therapy [ Time Frame: 9 months ]Sweating, dizziness, increased heart rate and arrhythmia, loss of appetite, diarrhea, constipation, nausea, irritability, insomnia, and allergic reactions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506841
|Mansoura University Children Hospital|
|Mansourah, El Dakahlya, Egypt, 35111|