Microbiota in Children With Severe Burn Injury

NCT07098377 | Active Not Recruiting

• 1 other identifier: 7327
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The research protocol consists of taking aliquots of biological specimens from skin swabs, nasopharyngeal swabs, and fecal swabs. the samples will be taken at time 0 of admission to the Pediatric ICU, one week after admission, and two weeks after admission to compare the bacterial populations present at the different sampling sites.

Conditions

Burn

Keywords

burns; microbiota; sepsis

Outcome Measures

Primary Outcomes (1)

• intestinal microbiota variation in burnt children

  concentration of microbiota population in pediatric population severely burnt

  21 days

Study Arms (1)

burns affected

Diagnostic Test: nasopharyngeal swab for biological sample analysis

Interventions

nasopharyngeal swab for biological sample analysis DIAGNOSTIC_TEST

nasopharyngeal swab for biological sample analysis

burns affected

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children suffering from burn trauma with signs and symptoms of burns, without antibiotic therapy in the previous 48 hours and without major congenital malformations. Authorization for data processing and participation in the study by the patient or their legal guardians is also considered.

You may qualify if:

• signs and/or symptoms of burn injury

You may not qualify if:

• major congenital malformation
• Antibiotic treatment 48 hours prior to admission
• failure to provide informed consent to participate in the protocol

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 06132, Italy

Location

MeSH Terms

Conditions

Burns; Sepsis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Orazio Genovese

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: April 7, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: two years

Locations

IT (1)