Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
Condition: Sequelae of Perinatal Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Intervention: Tenoten for children; Placebo
Intervention description: Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.; Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 29 Days
Maximum age: 9 Months
Healthy volunteers: No

Summary:

      Purpose of the study:

        -  To assess the clinical efficacy of Tenoten for children liquid dosage form therapy (10
           oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury
           (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial
           haemorrhage).

        -  To assess the safety of Tenoten for children liquid dosage form therapy (10 oral drops
           per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury
           (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial
           haemorrhage).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Full-term infants aged 29 days to 9 months.

          2. Diagnosis of Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral
             hypoxia-ischemia and/or mild-to-moderate intracranial hemorrhage).

          3. Total Jurba-Mastyukova score of < 27 (but > 12).

          4. Physical development parameters within 25-27 centiles.

          5. Neurologist's outpatient observation.

          6. Information sheet (informed consent form) for parents/adoptive parents for
             participation in the clinical study signed by the child's parents/adoptive parents.

        Exclusion Criteria:

          1. Previously diagnosed lesions, diseases and conditions:

             1.1. Cerebral ischemia (grade III). 1.2. Intraventricular hemorrhage (grade III). 1.3.
             Metabolic and toxic disorders affecting central nervous system (persistent neonatal
             hypoglycemia, hyperbilirubinemia associated with elevated indirect bilirubin, and
             other severe conditions).

             1.4. Intracranial birth injury, focal impairments due to brain injuries (pareses and
             paralyses).

             1.5. Sequelae of birth injury to spinal cord, cranial nerves and peripheral nervous
             system (peripheral pareses and paralyses).

             1.6. Different types of hydrocephalus. 1.7. Symptomatic epilepsy and epileptic
             syndromes. 1.8. Sequelae of perinatal central nervous system (CNS) infectious diseases
             (injury to CNS caused by neonatal sepsis, encephalitis, meningitis,
             meningoencephalitis, ventriculitis).

             1.9. Infectious diseases including congenital diseases (cytomegalovirus infection,
             rubella, herpesvirus or enterovirus infection, toxoplasmosis, syphilis, HIV infection,
             etc.).

             1.10. Chronic respiratory diseases originating in the perinatal period, including
             bronchopulmonary dysplasia.

             1.11. Hereditary metabolic diseases including glycogen storage disease (glycogenoses,
             E74.0), galactose metabolism disorders (galactosemia, Е74.2), other carbohydrate
             metabolism disorders (Е74), glucosaminoglycan metabolism disorders
             (mucopolysaccharidoses, Е76), aromatic amino-acid metabolism disorders
             (phenylketonuria, tyrosinemia, etc, Е70), branched-chain amino-acid and fatty-acid
             metabolism disorders (maple-syrup-urine disease, Е71), mitochondrial myopathy (G71.3).

             1.12. Neurogenerative diseases including Huntington disease (G10), copper metabolism
             disorder (Wilson disease, Е83.0).

             1.13. Chromosomal abnormalities. 1.14. Congenital anomalies [malformations] and
             deformities including congenital anomalies of nervous system and malformations of
             internal organs.

             1.15. Congenital endocrine diseases (congenital hypothyroidism, hypoparathyroidism,
             adrenocortical dysfunction).

             1.16. Malignant neoplasm / suspected malignant neoplasm.

          2. Acute infectious disease, exacerbation / decompensation of diseases that may prevent
             the patients' participation in the clinical study.

          3. Allergy/intolerance of any of the study treatment medications components.

          4. Drug addiction, alcohol use in the volume over 2 alcohol units/day by the subject's
             parent(s)/adoptive parent(s).

          5. Mental disorders of the patient's parent(s)/adoptive parent(s).

          6. Participation in other clinical studies for a period prior to and during the course of
             this trial.

          7. Other conditions complicating the subject's participation in the study (cannot make
             regular medical visits, moving, etc.).

          8. Subjects whose parent(s)/adoptive parent(s), from the investigator's point of view,
             will not follow the study requirements or comply with the dosing regimen.

          9. Patients whose parent(s)/adoptive parent(s) are related research staff of the clinical
             investigative site who are directly involved in the study or is a close relative of
             the investigator. Close relatives include spouse, parents, children or brothers
             (sisters) regardless of whether they are biological or adoptive ones.

         10. Patients whose parent(s)/adoptive parent(s) is working in OOO "NPF "Materia Medica
             Holding", i.e. is the company official, temporary contract worker or an appointed
             official responsible for the study or their close relatives.