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

• Status: Terminated
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• gestational age between 24 weeks + 0 and 27 weeks + 6 days

• Delivery imminent spontaneous defined by cervical dilation greater than or equal to 3 cm and regular contractions, painful (greater than or equal to 2 every 10 minutes) or elective caesarean section.

• maternal age ≥18 years at baseline

• written consent and

• Joining a social security scheme mother and holders of parental authority

Exclusion Criteria:

• Related to the parent criteria:

• Delivery Outborn

• Magnesium Sulphate injection in mother

• Chronic renal and hepatic impairment before pregnancy

• Circumstances of maternal or fetal distress requiring emergency cesarean eclampsia, placental abruption, placenta previa bleeding.