the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Down syndrome is a genetic disorder that causes delay in both physical growth and mental
      development. It is the most frequently reported chromosomal abnormality and the most common
      genetic syndrome.

      Down syndrome is caused by trisomy of all or part of the genetic material of human chromosome
      21. It is now estimated that 94% of individuals with Down syndrome have an extra chromosome
      21 as a result of meiotic non-disjunction, or the abnormal segregation of chromosomes during
      maternal gamete formation and of the remaining 5%, less than 1% is due to somatic mosaicism
      and the rest is due to chromosome 21 translocations.

      The estimated incidence of Down syndrome is between 1 / 1,000 to 1 / 1,100 live births
      worldwide. In Egypt, the incidence of Down syndrome has been reported to be 1 / 1000 live
      births.

      Down syndrome is characterized by intellectual disability, short stature, distinctive facial
      characters and a number of co-morbidities including cardiac and digestive anomalies, thyroid
      problems, and childhood leukemia.

      Down syndrome infants will likely experience delays in certain areas and aspects of
      development. However, they will achieve all of the same milestones as other normal children,
      just on their own timetable.

      According to recent studies, the Down syndrome behavioral phenotype includes relative
      strengths in some aspects of visuo-spatial processing and social functioning as well as
      relative deficits in verbal processing. Language has been described as a "major area of
      deficit" in Down syndrome individuals with particular difficulties manifested in expressive
      language.

      Due to this high incidence of Down syndrome in Egypt and the associated co-morbidities,
      governmental care directed to this syndrome and other handicapping conditions has increased
      tremendously in the past few years to the extent that Down syndrome phenotype has become a
      phobia and many parents and/or physicians referred normal babies for karyotype due to either
      suspicion of chromosomal anomalies or just for reassurance of their parents.

      Although there has been enormous progress in the management of the physical aspects of Down
      syndrome e.g. repair of heart defects, little advancement has been made to prevent
      deterioration of cognitive function in these individuals. As a result, the dramatic increase
      in life expectancy of children with Down syndrome in the past few decades has not been
      paralleled with concurrent treatment for cognitive disabilities. Therefore, it has remained
      the most common cause of cognitive dysfunction in children.

      The pathogenesis of cognitive deficits and motor disabilities in Down syndrome individuals
      can be attributed to diminished number and size of neuronal density, progressive neuronal
      degeneration, impairment of neurogenesis, and reduction in dendrite formation as well as
      spine density which results in disruption of synaptic function and plasticity. Therefore,
      many of these individuals develop increasing problems with learning and memory in later life.

      Cerebrolysin® is a neurotrophic peptidergic mixture isolated from pig brain. It is produced
      by standardized enzymatic breakdown of lipid-free porcine brain proteins .

      It acts similar to endogenous neurotrophic factors in the form of promoting neuronal
      sprouting, stimulating neurogenesis, enhancing neuronal plasticity, and improving learning
      and memory.

      Several studies demonstrated that Cerebrolysin® can be used safely in the management of
      children with any of the following medical conditions: minimal cerebral dysfunction,
      resistant forms of nocturnal enuresis, neurosensory hypoacusis, attention deficit
      hyperkinetic disorder, autism and Asperger syndrome.

      The overall aim of the study is to assess the effect of Cerebrolysin® on neurocognitive
      development of infants with Down syndrome.
    


Intervention name(s): cerebrolysin
Intervention type(s): Drug
Intervention description(s): Infants of the treatment group were given Cerebrolysin in a dose of 0.1 ml / kg body weight once weekly intramuscular injection for 12 month (total of 48 injections).Each selected infant, in both treatment and control group, was assessed as regard: Socioeconomic status, Nutritional status and feeding practice, assessed for neurocognitive development
Intervention MeSH terms: Cerebrolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment