Infant, Premature
Conditions
Brief summary
The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.
Detailed description
The secondary objectives are to study the links between changes of the intestinal microbiota premature infants in terms of: * changing diversity of the microbiota in the first 6 weeks of life; * changes in the bacterial community (UniFrac study) during the first 6 weeks of life; * diversity of the microbiota up to 6 weeks; -AND- * diversity of the microbiota at 1, 2 & 3 years; * bacterial communities (UniFrac study) at 1, 2 & 3 years; * lymphocyte subpopulation profiles at 3 years; * serum immunoglobulin A, G, M, E levels at 3 years; * history of infectious episodes, allergic and inflammatory episodes during the first 3 years of life. The links between certain variables known in the literature and neonatal microbiota will be confirmed / studied in our population: * mode of delivery; * length (and type) of antibiotic therapy in the neonatal period; * duration of breastfeeding.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence/absence of a Th1 type immune orientation | 36 months | Immune orientation will be determined according to the following ratio determined by lymphocyte stimulation tests: INF-gamma/(INF-gamma+IL+4). The latter ratio varies between 0 and 0.5 with IL-4 \> INF-gamma (TH2 orientation) and between 0.5 and 1 when INF-gamma \> IL-4 (TH1 orientation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood lymphocyte subset determination | 36 months | Subsets are determined according to the presence/absence of the following differentiation clusters: CD3, CD4, CD8, CD19, CD25, CD56, CD127, FOXP3. |
Countries
France
Contacts
STUDY_DIRECTORAnne Filleron, MD, PhD
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed