Gut Bacteria and Brain of the Baby (BaBBa)

Rennes University Hospital

Status

Enrolling

Conditions

Premature

Treatments

Other: Data collection of environmental factors

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

Other: food questionnaire

Other: The 'Ages and Stages Questionnaire' ASQ

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

Other: Sample of milk

Other: Collection of maternal feces

Other: Collection of infant feces

Study type

Interventional

Funder types

Other

Identifiers

NCT04432636

35RC19_9784_BaBBa

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

30 to 32 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Prospective French population based cohort

Other group

Description:

* 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

Treatment: