Sequelae of Perinatal Brain Injury Clinical Trial
Official title:
Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
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).
n/a