Gut Bacteria and Brain of the Baby

NCT04432636 | Recruiting

• 1 other identifier: 35RC19_9784_BaBBa
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature

Outcome Measures

Primary Outcomes (1)

• to associate preterms microbial profiles and psychomotor outcomes at 2 years of corrected age using the 'Ages and Stages Questionnaire' ASQ survey

  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.

  at 2 years of corrected age

Secondary Outcomes (12)

• 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 1 year of corrected age

• Bacterial and fongal microbiotas

  at 2 years of corrected age

• maternal dietary profiles and maternal microbiota

  up to 8 weeks after delivery

Study Arms (1)

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

Other: Data collection of environmental factors; Other: Collection of maternal feces; Other: Collection of infant feces; Other: food questionnaire; Other: a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age; Other: a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age; Other: Sample of milk; Other: The 'Ages and Stages Questionnaire' ASQ

Interventions

Data collection of environmental factors OTHER

\- Data collection of environmental factors (including maternal nutrition and social level, mode of delivery, birth weight, mode of infant feeding, antibiotic treatments) at the recruitment

Prospective French population based cohort

Collection of maternal feces OTHER

\- Collection of maternal feces: the first sample after delivery and once a week during the period of hospitalization of their infant (i.e. 5 to 8 samples per mother)

Prospective French population based cohort

Collection of infant feces OTHER

\- Collection of infant feces: the first sample after birth and once a week during the period of hospitalization of the baby (i.e. 5 to 8 samples per mother) and a sample collected at the corrected age of 1 year and 2 years (i.e. 8 to 10 samples per infant)

Prospective French population based cohort

food questionnaire OTHER

\- A food questionnaire completed by the mother the week after delivery,

Prospective French population based cohort

a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age OTHER

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

Prospective French population based cohort

a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age OTHER

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

Prospective French population based cohort

Sample of milk OTHER

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).

Prospective French population based cohort

The 'Ages and Stages Questionnaire' ASQ OTHER

\- 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

Prospective French population based cohort

Eligibility Criteria

• Age: 30 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes - Hôpital Sud

Rennes, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Aging

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Central Study Contacts

Amandine BELLANGER

CONTACT

02 99 23 48 21; amandine.bellanger@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: June 16, 2020
• Study Start: March 29, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

FR (1)