Clinical trial NCT04432636: Gut Bacteria and Brain of the Baby
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Preterms born with a genetic disease
* Preterms born with a digestive defect
* Uncompetent parents under the protection of guardianship or tutelage services

Primary outcomes:
measure: to associate preterms microbial profiles and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' ASQ survey
timeFrame: at 2 years of corrected age
Secondary outcomes:
measure: interactions between maternal and neonatal microbiotas - 2
timeFrame: at 2 years of corrected age
measure: interactions between maternal and neonatal microbiotas - 1
timeFrame: at 1 year of corrected age
measure: Bacterial and fongal microbiotas
timeFrame: at 1 year of corrected age
measure: Bacterial and fongal microbiotas
timeFrame: at 2 years of corrected age
measure: maternal dietary profiles and maternal microbiota
timeFrame: up to 8 weeks after delivery
measure: maternal dietary profiles and maternal microbiota
timeFrame: up to one week after delivery
measure: maternal dietary profiles and maternal milk composition
timeFrame: at the 7th postnatal day
measure: maternal dietary profiles, maternal milk composition and preterms gut microbiotas
timeFrame: Up to the 2 years of the baby
measure: Dietary profile and gut microbia composition
timeFrame: at 1 year of corrected age
measure: Dietary profile and gut microbia composition
timeFrame: at 2 years of corrected age
measure: Gut microbia
timeFrame: at 1 year of corrected age
measure: Gut microbia
timeFrame: at 2 years of corrected age
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes - Hôpital Sud
Study officials:
References: