Melatonin Levels in Preterm and Term Newborn Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Measurements of melatonin levels by radioimmunology
研究概览
简要总结
The general goal of the present study is to examine the developmental changes caused by melatonin in preterm and term newborns.
The major brain lesions associated with cerebral palsy and cognitive impairment in preterm infants are periventricular white matter damage (WMD). At the present time, despite major improvements in neonatal care, there are no established therapeutic regimens for the treatment of brain lesions in preterms. Melatonin is secreted by the pineal gland; melatonin's neuroprotective action has been well documented in animal experimental models. Neuroprotection is believed to stem from its direct free radical scavenging, indirect antioxidant activities.
Originality Several reports have described melatonin secretion in older children, but only a few have observed melatonin concentrations during the first year of life. Very little is known about the fetal pineal melatonin synthesis and nothing at what prenatal age melatonin synthesis starts. Premature infants have a 3 months delay in the development of melatonin rhythmicity compared to full-term infants. One study found discordant data with decreasing melatonin value around term. The absence of longitudinal study and the low number of children included make the interpretation difficult of the secretion of melatonin at the newborn.
Hypothesis: Infants born before 28 weeks gestation have melatonin deficiency (50pg/ml), compared to newborns at term (100pg/ml).
Study design: prospective, longitudinal, multicenter trial in 3 Neonatal Intensive Care Units in Ile de France. Specific aim is to compare the developmental changes of melatonin in preterm and term newborns (200 infants and their mothers: 4 groups of 50 infants: 24-27GA +6d ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following:
- determine Melatonin creatinin excretion in preterm infants
- correlate between serum melatonin secretion and urinary melatonin and 6-sulfatoxymelatonin excretion
- determine endogenous melatonin production in the human pineal
- correlate genetic variations between different levels of melatonin in premature infants
- assess clinical and neurological outcomes at term Clinical impact The present clinical project is part of a translational approach, expected data for infants born before 28 weeks gestation is melatonin deficiency which should participate in determining the potential use of melatonin as a neuroprotectant in human preterm neonates.
详细描述
The general goal of the present study is to examine the developmental changes caused by melatonin in preterm compared to term newborns. This secretion is studied in child and mother's blood, child's urine, the mother's milk for the women who breastfeed (200 infants and their mothers: 4 groups of 50 infants: 24-27 gestational age (GA) +6d ; 28-32 GA +6d ; 33-36 GA +6d ; 37-41 GA +6d). Secondary aims are the following: determine Melatonin creatinin excretion in preterm infants, correlate between serum melatonin secretion and urinary melatonin and 6-sulfatoxymelatonin excretion, determine endogenous melatonin production in the human pineal, correlate genetic variations between different levels of melatonin in premature infants, assess clinical and neurological outcomes at term.
Study duration for each patient Study duration is one year (inclusion time: 9 months) Duration of mother's inclusion:3 days if delivery between 34 and 41+6d weeks of gestation (two blood samples in maternal vein and umbilical vein after delivery and one mother's milk sample on the third day after delivery, D3) 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation (two blood samples in maternal vein and umbilical vein after delivery and mother's milk sample on the third day after delivery,D10-D15, D30, D60 until term age
Duration of infant's inclusion:
- 3 days if delivery between 34 and 41+6d weeks of gestation (1 blood sample on the third day (D3) after delivery and 4 urinary samples at birth and on D3)
- 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation (blood and urinary samples on the third day after delivery,D10-D15, D30, D60 until term (37-42 weeks gestational age)
Population study All the preterm and term newborns in 3 participating centers, will be evaluated in term of eligibility. Their clinical characteristics will be compared to the criteria of inclusion and exclusion before entering into the study. The inclusion of the preterm from 24 GA is justified by the assumption of responsibility of more in earlier of this population in 2009 (limit of viability from 24 GA and/or birth weight > 500g).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent forms from mother or guardian
- •Age ≥ 18 years
- •Mother Heath insurance
- •Infants born between 24+0 et 41+6 weeks of gestation
- •Infants with informed consent from mother or guardian and mother's social insurance
排除标准
- •Chronic pathology
- •Treatment: Carbamazepine, betablockers, rifampicin, quinolones, cimetidine, 5-Methoxypsoralen or bergapten, 8- methoxypsoralen (or Methoxsalen), CIRCADIN®
- •Newborn :
- •Congenital malformations
- •Dermatosis
- •Treatment: cimetidine
结局指标
主要结局
Measurements of melatonin levels by radioimmunology
时间窗: 15 days to 3 months if delivery between 24 and 33+6d weeks of gestation
Primary outcomes are measurements of melatonin levels in urine, blood, milk. These procedures will be made by radioimmunology, to limit data variability. The reasoning will be made in coefficient of variation intra-test for a patient.
次要结局
- Serum Cortisol concentrations and urinary excretion(15 days to 3 months if delivery between 24 and 33+6d weeks of gestation)
- Serum Serotonin level(15 days to 3 months if delivery between 24 and 33+6d weeks of gestation)