Actively Recruiting
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
Led by Rennes University Hospital · Updated on 2023-03-28
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying premature babies born between 30 and 32 6/7 weeks of gestation to understand how gut bacteria affect their brain development and psychomotor skills by the age of 2 years. This French population-based study will follow about 100 moderate preterm infants admitted to the neonatal intensive care unit of Rennes Hospital. The goal is to link the dynamic of gut colonization with the baby's development using surveys and biological samples. The study involves collecting environmental data about the baby and mother, including maternal nutrition and social factors, mode of delivery, birth weight, feeding methods, and antibiotic treatments. Researchers will collect maternal feces samples weekly during the baby's hospitalization and infant feces samples from birth through 2 years of corrected age. Parents will complete food questionnaires at several points during the baby's first two years, and a milk sample from the baby at about 7 days old will be collected. The Ages and Stages Questionnaire (ASQ) will be completed by parents at 2 years to assess psychomotor development. Participants will be followed longitudinally until 2 years corrected age through pediatric check-ups where collected data and samples will be reviewed. The study will measure the association between gut microbial profiles and psychomotor outcomes using the ASQ at 2 years. Secondary assessments include interactions between maternal and neonatal microbiotas, dietary profiles, and milk composition. Continuous monitoring and data collection will provide insights into how early gut colonization relates to later development in preterm infants.
CONDITIONS
Brief Title
Gut Bacteria and Brain of the Baby
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Preterms born with a genetic disease
- Preterms born with a digestive defect
- Uncompetent parents under the protection of guardianship or tutelage services
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at recruitment
Duration - From birth up to 2 years
Participants provide various biological samples including maternal and infant feces, and milk samples to study gut bacteria dynamics.
Weekly collection of feces samples during hospitalization and samples collected at 1 year and 2 years corrected age; 1 milk sample at around the 7th postnatal day
Duration - From delivery up to 2 years
Parents complete food questionnaires about maternal and infant nutrition and infant food behavior at several time points.
Questionnaire at 1 week after delivery, at 1 year, and at 2 years corrected age
Duration - At 2 years corrected age
Parents complete the 'Ages and Stages Questionnaire' (ASQ) to assess the baby's psychomotor development at 2 years corrected age.
1 visit (in-person) at 2 years medical check-up
Trial Site Locations
Total: 1 location
1
CHU Rennes - Hôpital Sud
Rennes, France
Actively Recruiting
Research Team
A
Amandine BELLANGER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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