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

NCT02395783 | Terminated Phase 2

• 1 other identifier: P120113
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Birth

Keywords

Preterm infants; diagnosis of cerebral white matter injury

Outcome Measures

Primary Outcomes (1)

• TBSS analysis

  The primary endpoint will be the analysis of white matter injury (LSB) at 40 weeks corrected by brain MRI with diffusion tensor sequence (TBSS analysis).

  40 weeks

Secondary Outcomes (4)

• measurement of plasma melatonin levels

  before injection of the drug, 5 minutes, 1 hour, 3 hours, 4 hours and 5 hours after injection of the drug

• Plasma melatonin level

  Day 1

• Neurological evaluation (revised Brunet-test)

  2 years

• Mortality

  28 days of life

Study Arms (3)

Melatonin dose1

ACTIVE COMPARATOR

Melatonin 10 µg

Drug: Melatonin 10 µg

Melatonin dose2

ACTIVE COMPARATOR

Melatonin 20 µg

Drug: Melatonin 20 µg

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Melatonin 10 µg DRUG

Determine the dose of prenatal administration of melatonin in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) analysis with spatial statistics (TBSS) to the theoretical term 40 weeks

Melatonin dose1

Melatonin 20 µg DRUG

Determine the dose of prenatal administration of melatonin in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) analysis with spatial statistics (TBSS) to the theoretical term 40 weeks

Melatonin dose2

Placebo OTHER

Determine the dose of prenatal administration of melatonin in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) analysis with spatial statistics (TBSS) to the theoretical term 40 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Robert Debré

Paris, 75019, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Biran Valérie, PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 24, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-02

Locations

FR (1)