Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.
- Conditions
- Neonatal Sepsis
- Interventions
- Other: Collection of breast milk
- Registration Number
- NCT05490498
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- Brief Summary
Breast milk contains many microorganisms including bacteria that are beneficial to health (probiotics), but also bacteria that are generally considered pathogenic.
Several studies have described an increased risk of infections due to pathogenic germs in breast milk in premature newborns whose digestive system is immature and whose digestive flora is modified by repeated antibiotic treatments.
However, a breastfed baby is better protected against infectious diseases than a bottle-fed baby. The objective of this study is to define the breast milk microbiota of infants with confirmed early or late neonatal bacterial infection compared to the breast milk microbiota of infants with no evidence of bacterial infection. For that purpose, an exploration will be performed using the principle of "Microbial Culturomics" and targeted metagenomics (16S ribosomal RNA gene sequencing).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 75
Breastfeeding mothers of infants:
- Aged 1 to 89 days consulting in hospitals in the Marseille area (Assistance Publique des H么pitaux de Marseille: H么pital de la Timone-enfants and H么pital Nord),
- Suspected neonatal bacterial infection due to the presence of fever (rectal or axillary temperature > 38掳C),
- In whom bacteriological samples have been taken (cerebrospinal fluid, joint fluid, blood cultures, urine),
- Patients affiliated or benefiting from a social security system.
- Exclusive formula milk feeding
- Opposition of legal guardians
- No bacteriological sample to prove infant infection
- No confirmation of fever by standardized method
- Opposition to participating in the study
- Neonatal hospitalization > 48 hours for management of prematurity.
- Severe congenital malformations in the infant.
- Antibiotic treatment for a concomitant bacterial infection in the infant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Breastfeeding mother Collection of breast milk Breastfeeding mother with infants between 1 and 89 days of age who presented with suspected neonatal bacterial sepsis due to the presence of a fever.
- Primary Outcome Measures
Name Time Method Description of bacterial carriage of breast milk 18 months Identify the bacterial carriage of breast milk of infants with neonatal sepsis. Microbial anlaysis of mother's milk from baby with neonatal sepsis.
- Secondary Outcome Measures
Name Time Method Comparison of breast milk of infants with neonatal sepsis to infants without neonatal sepsis. 18 months Compare the bacterial carriage (type of germs found) of the breast milk of infants with neonatal sepsis to breast milk of infants with fever for another cause (virus, non identified germ)
Comparison of milk germs to children's germs. 18 months Compare the germs found in the breast milk of each mother-infant pair with a bacterial infection with the germs identified in the infant.
Comparison of microbiota profiles in breast milk 18 months Compare the bacterial composition of the breast milk of mother-infant pairs with the same germ (germ infecting the child identical to the germ identified in the mother's milk) versus mother-infant pairs with a different germ in the milk (no germ found in the child when a germ was identified in the breast milk, or germ infecting the child different from the germ identified in the mother's milk).
Trial Locations
- Locations (1)
Hopital de la Timone
馃嚝馃嚪Marseille, France