drugset / Trial / NCT02395783

Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease

NCT02395783

Phase 2/3 Terminated 14 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupDouble-blindTreatment

Summary

Neurocognitive sequelae observed in preterm represent a major health problem for which there is no preventive treatment approved to date. These effects are the result of a multifactorial brain damage occurring in developing prenatal and perinatal period. Melatonin, the principal hormone secreted by the pineal gland has neuroprotective properties in various experimental animal models of perinatal brain damage level. This hormone readily crosses the placental barrier, its antenatal administration would have a neuroprotective effect in the case of preventive preterm birth before 28 weeks of amenorrhea. The objective of this study determine the dose of melatonin administered parenterally in prenatal maternal in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) with statistical spatial analysis (TBSS) to the theoretical term of 40 weeks in children born prematurely.

Timeline

Start
2015-03
Primary completion
2018-02
Completion
2018-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 10 ug Intravenous
Comparator Melatonin Small molecule 20 ug Intravenous

Indications

No indication recorded.