Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease in Very Preterm Infants
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- TBSS analysis
研究概览
简要总结
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.
详细描述
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 gestation.
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.
Secondary objectives:
-
Determine the pharmacokinetics of melatonin administered intravenously in two dosage regimens and after randomization in pregnant women under 28 weeks
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Assess the contribution of antenatal injection of melatonin on the incidence of white matter injury detected by conventional brain MRI
-
Assess the contribution of antenatal injection of melatonin on the rate of neurological sequelae at 2 years corrected age, mortality at 28 days of life and at the end of hospitalization.
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Evaluate the adverse effects of melatonin injection
-
Selection criteria (inclusion and non-inclusion)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Melatonin dose1
Melatonin 10 µg
干预措施: Melatonin 10 µg (Drug)
Melatonin dose2
Melatonin 20 µg
干预措施: Melatonin 20 µg (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
TBSS analysis
时间窗: 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).
次要结局
- 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)