Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
Sequelae of Perinatal Brain Injury
About this trial
This is an interventional treatment trial for Sequelae of Perinatal Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Full-term infants aged 29 days to 9 months.
- Diagnosis of Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral hypoxia-ischemia and/or mild-to-moderate intracranial hemorrhage).
- Total Jurba-Mastyukova score of < 27 (but > 12).
- Physical development parameters within 25-27 centiles.
- Neurologist's outpatient observation.
- 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:
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.
- Acute infectious disease, exacerbation / decompensation of diseases that may prevent the patients' participation in the clinical study.
- Allergy/intolerance of any of the study treatment medications components.
- Drug addiction, alcohol use in the volume over 2 alcohol units/day by the subject's parent(s)/adoptive parent(s).
- Mental disorders of the patient's parent(s)/adoptive parent(s).
- Participation in other clinical studies for a period prior to and during the course of this trial.
- Other conditions complicating the subject's participation in the study (cannot make regular medical visits, moving, etc.).
- 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.
- 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.
- 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.
Sites / Locations
- State Budgetary Healthcare Institution of Sverdlovsk Region Children's Clinical Hospital of Rehabilitation The Scientific and Practical Center "Bonum"
- Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
- Pirogov Russian National Research Medical University
- I.M. Sechenov First MSMU
- Moscow Regional Research and Clinical Institute ("MONIKI")
- Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
- State budgetary institution of public health of the Samara region "Samara City Children's Clinical Hospital No. 1 named after N.N. Ivanova"
- LLC "Center for DNA Research"
- LLC Nebbiolo
- Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Tenoten for children
Placebo