CHU Rennes - Hôpital Sud
Rennes, France
NCT Number: NCT04432636
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.
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Notify Me30 week–32 week
All sexes
Interventional
Not applicable
Rennes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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 (if not possible between the 7th and the 10th postnatal days).
Time frame: 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.
Time frame: at 2 years of corrected age
Pearson correlation values between maternal microbiota composition and infant gut microbiota composition from birth up to 2 years at corrected age..
Time frame: at 1 year of corrected age
.Pearson correlation values between maternal microbiota composition and infant gut microbiota composition from birth up to 1 year at corrected age.
Time frame: at 1 year of corrected age
Pearson correlation values between bacterial (16S) and fongal (18S) microbiota composition in infant from birth up to 1 year at corrected age.
Time frame: at 2 years of corrected age
Pearson correlation values between bacterial (16S) and fongal (18S) microbiota composition in infant from birth up to 2 years at corrected age.
Time frame: up to 8 weeks after delivery
Time frame: up to one week after delivery
Time frame: at the 7th postnatal day
Time frame: Up to the 2 years of the baby
Time frame: at 1 year of corrected age
Correlation between 1-y infant dietary profile and 1-y infant gut microbiota composition. Associations between infant dietary profiles and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin) and by applying Markov Decision Process (MDPs) to take into account the analysis of microbiota dynamics
Time frame: at 2 years of corrected age
Correlation between 1-y infant dietary profile and 2-y infant gut microbiota composition. Associations between infant dietary profiles and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin) and by applying Markov Decision Process (MDPs) to take into account the analysis of microbiota dynamics
Time frame: at 1 year of corrected age
Functional activity of gut microbiota (in vitro test using 1-y infant fecal samples). Endocrine and barrier function responses of an in vitro tricellular model of intestinal epithelium (including enterocytes, mucin-secreting cells and entero-endocrine cells) to the stimulation by fecal water from 1-y infant feces will be characterized.
Time frame: at 2 years of corrected age
Functional activity of gut microbiota (in vitro test using 1-y infant fecal samples). Endocrine and barrier function responses of an in vitro tricellular model of intestinal epithelium (including enterocytes, mucin-secreting cells and entero-endocrine cells) to the stimulation by fecal water from 1-y infant feces will be characterized.
Rennes University Hospital
Other
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
Acronym: BaBBa
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