PrimiBiotaIntestinal Microbiota Impact on Premature Infants' Immunity at Age 3
The study aims to observe how the intestinal microbiota affects the immune system of premature infants by the time they reach three years old.
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+3
+ Female Urogenital Diseases and Pregnancy Complications
+ Obstetric Labor Complications
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: May 12, 2017
Actual date on which the first participant was enrolled.This study focuses on understanding how the gut bacteria of premature infants develop and how it affects their immune system by the time they reach three years old. It explores how factors like the diversity and type of bacteria in their intestines evolve over time and its impact on their health. The study is particularly important for premature infants as they often face unique health challenges. By examining these changes, researchers hope to find better ways to support the development of a healthy immune system, potentially reducing the risk of infections, allergies, and inflammation in young children. Participants in this observational study involve premature infants whose gut bacteria will be monitored over time. Researchers will analyze samples to observe changes in bacterial diversity during the first six weeks of life and then again at ages one, two, and three years. They will also assess the children's immune system by looking at specific blood markers and their history of infections and allergic reactions. The study also considers how factors like the type of delivery, duration of breastfeeding, and antibiotic use in the neonatal period influence these changes. The goal is to determine if these early influences on gut bacteria can predict the direction of the immune system's development.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.130 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * The parents of the patient (or legal guardian if any) have been informed about the implementation of the study, its objectives, its constraints, and patient rights * The parents of the patient (or legal guardian if any) must have given their free and informed consent and signed the consent form * The patient must be affiliated with or beneficiary of a health insurance plan * Premature infants born at less than 33 weeks of gestation Exclusion Criteria: * The patient is participating in another interventional study (Excepted " Recherche du Portage de Clostridium butyricum et de Toxines de Clostridium chez les Prématurés Hospitalisés en Néonatologie afin de prédire la survenue d'Entérocolites Nécrosantes", RCB 2016-A00-529-42 ; " BetaDose Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth ", RCB 2016-001486-90. * It is not possible to correctly inform the parent (or legal guardian, if applicable) * A serious deformity or digestive malformation was diagnosed at birth * During the hospital stay in the neonatology department, the patient had a digestive disease requiring surgery (except necrotizing enterocolitis) * A transfer to another hospital is foreseen/predictable (eg, due to geographical distance)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, FranceOpen CHRU de Montpellier - Hôpital Arnaud de Villeneuve in Google MapsCHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, FranceRéseau GRANDIR EN LANGUEDOC-ROUSILLON
Saint-Gély-du-Fesc, France