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

NCT05490498 | Unknown

• 2 other identifiers: 2021-11ID-RCB
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Description of bacterial carriage of breast milk

  Identify the bacterial carriage of breast milk of infants with neonatal sepsis. Microbial anlaysis of mother's milk from baby with neonatal sepsis.

  18 months

Secondary Outcomes (3)

• Comparison of breast milk of infants with neonatal sepsis to infants without neonatal sepsis.

  18 months

• Comparison of milk germs to children's germs.

  18 months

• Comparison of microbiota profiles in breast milk

  18 months

Study Arms (1)

Breastfeeding mother

EXPERIMENTAL

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.

Other: Collection of breast milk

Interventions

Collection of breast milk 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.

Breastfeeding mother

Eligibility Criteria

• Gender Eligibility Details: Breastfeeding mothers
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hopital de la Timone

Marseille, France

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François CREMIEUX

  ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE

  STUDY DIRECTOR

Central Study Contacts

Lucile LESAGE

CONTACT

0491386817; Lucile.LESAGE@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: July 13, 2022
• Primary Completion: July 12, 2024
• Study Completion: December 12, 2024
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)