NCT04432636

Gut Bacteria and Brain of the Baby

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 30 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
OTHER	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)
OTHER	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)
OTHER	food questionnaire	\- A food questionnaire completed by the mother the week after delivery,
OTHER	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
OTHER	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
OTHER	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).
OTHER	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

Timeline

• Start date: 2021-03-29
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2020-06-16
• Last updated: 2023-03-28

Locations

1 site across 1 country: France