Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.

NCT ID: NCT05490498

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2024-12-12

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).

Conditions

Neonatal Sepsis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Breastfeeding mother

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.

Group Type: EXPERIMENTAL

Collection of breast milk

Intervention Type: OTHER

Collection of breast milk through a sterilized breastfeeding device. Once the collection is completed, the milk will be transferred to a sterile jar provided in a dedicated survey package for transport to the laboratory.

Interventions

Collection of breast milk

Collection of breast milk through a sterilized breastfeeding device. Once the collection is completed, the milk will be transferred to a sterile jar provided in a dedicated survey package for transport to the laboratory.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Breastfeeding mothers of infants:

• Aged 1 to 89 days consulting in hospitals in the Marseille area (Assistance Publique des Hôpitaux de Marseille: Hôpital de la Timone-enfants and Hôpital Nord),
• Suspected neonatal bacterial infection due to the presence of fever (rectal or axillary temperature > 38°C),
• In whom bacteriological samples have been taken (cerebrospinal fluid, joint fluid, blood cultures, urine),
• Patients affiliated or benefiting from a social security system.

Exclusion Criteria

• 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François CREMIEUX

Role: STUDY_DIRECTOR

ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE

Locations

Hopital de la Timone

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lucile LESAGE

Role: CONTACT

Lucile.LESAGE@ap-hm.fr

0491386817 ext. 33

Facility Contacts

Aurélie Morand

Role: primary

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

2021-11

Identifier Type: -

Identifier Source: org_study_id