Trials / Active Not Recruiting
Active Not RecruitingNCT07098377
Microbiota in Children With Severe Burn Injury
Gut, Nasopharyngeal, and Skin Microbiota in Children With Severe Burn Injury: the Role in Infectious Complications in Burn Injury
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Pediatric burns (0-14 years) make up 26% of emergency room admissions for burns, with 73% of cases in children under 5 years old. The most common burns are thermal from boiling liquids, followed by open flames and fireworks. Severe burns (\>20% of body surface area) provoke a systemic inflammatory response that causes hypovolemia, tissue hypoperfusion, and metabolic stress, establishing a vicious cycle that is difficult to break. Burn trauma can also compromise the intestinal barrier, composed of cellular junctions (tight junctions), damage to which increases intestinal permeability. This promotes the passage of luminal contents into the systemic circulation, aggravating the immune and inflammatory response. Gut dysfunction is often accompanied by dysbiosis of the microbiota, with risk of bacterial translocation to sterile organs (liver, lungs, brain), contributing to systemic complications in critically ill patients. The study hypothesizes that burn trauma increases intestinal permeability, promoting bacterial translocation and anticipating infectious complications. Analyzing microbial populations at exposed sites (skin, gut, BAL) during trauma and pediatric ICU care may help to better understand the origin of septic complications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | nasopharyngeal swab for biological sample analysis | nasopharyngeal swab for biological sample analysis |
Timeline
- Start date
- 2025-04-07
- Primary completion
- 2026-04-01
- Completion
- 2026-07-01
- First posted
- 2025-08-01
- Last updated
- 2025-08-14
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT07098377. Inclusion in this directory is not an endorsement.