Actively Recruiting

Phase Not Applicable
Age: 30Weeks - 32Weeks
All Genders
ID04432636

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

Age: 30Weeks - 32Weeks
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at recruitment

Sample Collection

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

Questionnaire Assessments

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

Psychomotor Development Assessment

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

Loading map...

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

Similar Trials

Early DHA Supplementation in Growth-restricted Very Preterm ...

Infant Malnutrition

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here