NCT04432636已完成不适用
Gut Bacteria and Brain of the Baby: to Link up the Dynamic of Gut Colonization in Preterms Born at Gestational Age of 30-326/7 Weeks and Their Psychomotor Development at 2 Years
Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年3月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- to associate preterms microbial profiles and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' ASQ survey
研究概览
简要总结
The project is a prospective French population based cohort. A hundred moderate preterms born at GA30-326/7 will be enrolled for a longitudinal follow-up up to 2 years of corrected age. Eligible neonates will be those born at 30-326/7 weeks of gestation admitted to the neonatal intensive care unit of Rennes Hospital, including transferred infants during the first day of life. The infants will be followed up to the corrected age of 2 years by pediatricians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterms born at gestational age of 30-326/7 weeks of amenorrhea
- •Preterms born in Rennes hospital or preterms born in another hospital but moved to Rennes hospital during the first 24 h of postnatal life
- •Parents or holder of the parental authority who give in writing their free, prior and informed consent for recruitment of their baby who has a social security system
- •Mother of the baby who gives in writing her free, prior and informed consent to be involved in the present study
- •Mother of the baby who has a social security system
排除标准
- •Preterms born with a genetic disease
- •Preterms born with a digestive defect
- •Uncompetent parents under the protection of guardianship or tutelage services
研究组 & 干预措施
Prospective French population based cohort
Other
- Data collection of environmental factors at the recruitment
- Collection of maternal feces
- Collection of infant feces:
- A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
- A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
干预措施: Data collection of environmental factors (Other)
Prospective French population based cohort
Other
- Data collection of environmental factors at the recruitment
- Collection of maternal feces
- Collection of infant feces:
- A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
- A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
干预措施: Collection of maternal feces (Other)
Prospective French population based cohort
Other
- Data collection of environmental factors at the recruitment
- Collection of maternal feces
- Collection of infant feces:
- A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
- A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
干预措施: Collection of infant feces (Other)
Prospective French population based cohort
Other
- Data collection of environmental factors at the recruitment
- Collection of maternal feces
- Collection of infant feces:
- A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
- A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
干预措施: food questionnaire (Other)
Prospective French population based cohort
Other
- Data collection of environmental factors at the recruitment
- Collection of maternal feces
- Collection of infant feces:
- A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
- A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
干预措施: a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age (Other)
Prospective French population based cohort
Other
- Data collection of environmental factors at the recruitment
- Collection of maternal feces
- Collection of infant feces:
- A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
- A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
干预措施: a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age (Other)
Prospective French population based cohort
Other
- Data collection of environmental factors at the recruitment
- Collection of maternal feces
- Collection of infant feces:
- A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
- A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
干预措施: Sample of milk (Other)
Prospective French population based cohort
Other
- Data collection of environmental factors at the recruitment
- Collection of maternal feces
- Collection of infant feces:
- A food questionnaire completed by the mother the week after delivery, a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year and a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
- A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day
- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
干预措施: The 'Ages and Stages Questionnaire' ASQ (Other)
结局指标
主要结局
to associate preterms microbial profiles and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' ASQ survey
时间窗: at 2 years of corrected age
To associate preterms microbial profiles (bacteria and fungi; alpha- and beta-diversity, abundancies and complex interactions between neonatal microbiotas) and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' survey. Each questionnaire includes 30 items covering five developmental domains: communication abilities, gross motor skills, fine motor skills, problem solving abilities, and personal-social skills. Items are scored on a three point scale depending on whether the child performs the task: yes (10 points), sometimes (5 points), or not yet (0 points). Responses are summed to give a score of 0 to 60 for each domain and an overall maximum ASQ score of 300 points. Analyses were based on domain specific scores, using established screening cut-off points: an ASQ score below threshold was defined as a score lower than 2 standard deviations from the mean on any of the five domains.
次要结局
- maternal dietary profiles and maternal microbiota(up to one week after delivery)
- maternal dietary profiles and maternal milk composition(at the 7th postnatal day)
- maternal dietary profiles, maternal milk composition and preterms gut microbiotas(Up to the 2 years of the baby)
- maternal dietary profiles and maternal microbiota(up to 8 weeks after delivery)
- interactions between maternal and neonatal microbiotas - 2(at 2 years of corrected age)
- interactions between maternal and neonatal microbiotas - 1(at 1 year of corrected age)
- Bacterial and fongal microbiotas(at 2 years of corrected age)
- Dietary profile and gut microbia composition(at 2 years of corrected age)
- Gut microbia(at 2 years of corrected age)
- Bacterial and fongal microbiotas(at 1 year of corrected age)
- Dietary profile and gut microbia composition(at 1 year of corrected age)
- Gut microbia(at 1 year of corrected age)
研究者
研究点 (1)
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