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

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ClinicalTrials.gov Identifier: NCT02395783
Recruitment Status : Terminated
First Posted : March 24, 2015
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Premature Birth Drug: Melatonin 10 µg Drug: Melatonin 20 µg Other: Placebo Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease in Very Preterm Infants
Actual Study Start Date : March 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: Melatonin dose1
Melatonin 10 µg
Drug: Melatonin 10 µg
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

Active Comparator: Melatonin dose2
Melatonin 20 µg
Drug: Melatonin 20 µg
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 Comparator: Placebo
Placebo
Other: Placebo
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




Primary Outcome Measures :
  1. TBSS analysis [ Time Frame: 40 weeks ]
    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).


Secondary Outcome Measures :
  1. measurement of plasma melatonin levels [ Time Frame: before injection of the drug, 5 minutes, 1 hour, 3 hours, 4 hours and 5 hours after injection of the drug ]
    Pharmacokinetics of melatonin in the mother to determine the dose of Melatonin supplementation in pregnant women (between 24 weeks and 27 weeks + 6days)

  2. Plasma melatonin level [ Time Frame: Day 1 ]
    Plasma melatonin level measured in the mother and the newborn at birth (cord blood)

  3. Neurological evaluation (revised Brunet-test) [ Time Frame: 2 years ]
    Neurological evaluation at the age of 2 years by the revised Brunet-test skimped

  4. Mortality [ Time Frame: 28 days of life ]
    Mortality at 28 days of life and at discharge



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395783


Locations
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France
Hôpital Robert Debré
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Biran Valérie, PHD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02395783     History of Changes
Other Study ID Numbers: P120113
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Preterm infants
diagnosis of cerebral white matter injury
Additional relevant MeSH terms:
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Brain Injuries
Leukoencephalopathies
Premature Birth
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants