Cerebrolysin and Neurodevelopment in Preterm Infants

What Was Tested

The trial (phase 1) is built around Cerebrolysin.

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.

It had two arms (groups): Cerbrolysin (active comparator) and Control (no intervention).

Preterm infants with gestational age less than 32 weeks at birth will receive routine care.

The registry classes the interventions as drug.

More on the Plan

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.

The neurologic consequences of extreme prematurity range from mild behavioral and cognitive defects to severe disability.

Cerebrolysin is a porcine brain-derived peptide preparation that acts like endogenous neurotrophic factors.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 5 months up to 1 Year.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Infants with culture proven early or late onset neonatal sepsis with or without neonatal meningitis. Infants diagnosed to have peri- ventricular leukomalacia diagnosed by brain imaging.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: patient with persistent uncontrolled fits (all possible reasons for these uncontrolled seizures, including non-epileptic seizures, pseudo intractability, and medically refractory epilepsy; patient with brain malformation.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Cerebrolysin group and the comparison group should start out alike.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

In this single-blind Cerebrolysin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2016-06 with completion listed for 2019-06.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Neurodevelopmental outcome (time frame: 9 months).

It also tracked 1 secondary outcome, for example Side effects of cerebrolysin therapy.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cerebrolysin in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, all human trials.