Gut Bacteria and Brain of the Baby

Premature Clinical Trial

— BaBBa  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04432636
• Other study ID #: 35RC19_9784_BaBBa
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: September 2026

Study information

• Verified date: March 2023
• Source: Rennes University Hospital
• Contact: Amandine BELLANGER
• Phone: 02 99 23 48 21
• Email: amandine.bellanger[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature

Intervention

Other:
• Data collection of environmental factors
- 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
• Collection of maternal feces
- 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)
• Collection of infant feces
- 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)
• food questionnaire
- 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
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
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
• Sample of milk
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).
• The 'Ages and Stages Questionnaire' ASQ
- 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

Locations

Country	Name	City	State
France	CHU Rennes - Hôpital Sud	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	interactions between maternal and neonatal microbiotas - 2	Pearson correlation values between maternal microbiota composition and infant gut microbiota composition from birth up to 2 years at corrected age..	at 2 years of corrected age
Secondary	interactions between maternal and neonatal microbiotas - 1	.Pearson correlation values between maternal microbiota composition and infant gut microbiota composition from birth up to 1 year at corrected age.	at 1 year of corrected age
Secondary	Bacterial and fongal microbiotas	Pearson correlation values between bacterial (16S) and fongal (18S) microbiota composition in infant from birth up to 1 year at corrected age.	at 1 year of corrected age
Secondary	Bacterial and fongal microbiotas	Pearson correlation values between bacterial (16S) and fongal (18S) microbiota composition in infant from birth up to 2 years at corrected age.	at 2 years of corrected age
Secondary	maternal dietary profiles and maternal microbiota	- Correlation between maternal dietary profiles (food questionnaire completed by the mother the week after delivery) and maternal microbiota. Associations between clinical metadata, dietary profiles and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin).	up to 8 weeks after delivery
Secondary	maternal dietary profiles and maternal microbiota	- Correlation between maternal dietary profiles (food questionnaire completed by the mother the week after delivery) and maternal microbiota. Associations between clinical metadata, dietary profiles and microbial community abundance will be investigate by Multivariate Association with Linear Models (MaAslin).	up to one week after delivery
Secondary	maternal dietary profiles and maternal milk composition	- Correlation between maternal dietary profiles (food questionnaire completed by the mother the week after delivery) and maternal milk (a sample of milk drunk by the preterm at the 7th postnatal day, if not possible between the 7th and the 10th postnatal days) composition. The interactions will be assessed by Pearson correlation analysis and drewing the interaction network using Cystoscape package in R.	at the 7th postnatal day
Secondary	maternal dietary profiles, maternal milk composition and preterms gut microbiotas	- Correlation between maternal maternal dietary profiles (food questionnaire completed by the mother the week after delivery) and maternal milk (a sample of milk drunk by the preterm at the 7th postnatal day, if not possible between the 7th and the 10th postnatal days) composition and preterms gut microbiotas 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 infant) and a sample collected at the corrected age of 1 year and 2 years (i.e. 8 to 10 samples per infant). Associations between clinical metadata, dietary profiles and milk composition, 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	Up to the 2 years of the baby
Secondary	Dietary profile and gut microbia composition	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	at 1 year of corrected age
Secondary	Dietary profile and gut microbia composition	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	at 2 years of corrected age
Secondary	Gut microbia	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.	at 1 year of corrected age
Secondary	Gut microbia	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.	at 2 years of corrected age