Using AI to predict necrotizing enterocolitis in premature babies through stool analysis
Predictive Diagnosis of Ulcero-Necrotizing EnteroColitis in Premature Babies Using an Artificial Intelligence Approach Based on Early Analysis of the Fecal Microbiota
This study is trying to see if using AI to analyze stool samples from premature babies can help predict who is at risk for necrotizing enterocolitis, so doctors can take steps to prevent it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | N/A to 1 Day |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 5 sites (Clermont-Ferrand and 4 other locations) |
| Trial ID | NCT06727877 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a predictive diagnostic test for necrotizing enterocolitis (NEC) in premature infants by analyzing their fecal microbiota using artificial intelligence. Stool samples from infants up to 21 days old will be collected and analyzed through metagenomic sequencing to identify risk factors for NEC. The study will classify infants as at risk or not based on the analysis of their stool samples, allowing for personalized preventive measures. Clinicians will diagnose NEC according to the Bell classification, and follow-up will be conducted to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants born before 34 weeks of gestation who are hospitalized in neonatal intensive care units.
Not a fit: Patients who are not premature or those whose guardians are legally protected may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence and mortality of necrotizing enterocolitis in premature infants by enabling early intervention.
How similar studies have performed: While the use of artificial intelligence in microbiota analysis is a novel approach, similar studies have shown promise in predicting other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Child born prematurely (i.e. before 34 weeks of amenorrhea) in one of participating university hospitals and hospitalized in neonatal intensive care units of the AURA region's university hospitals * Child born outside CHU and transferred before 24h of life to the neonatal intensive care unit of one of thehospital participating in the study * Affiliated with a Social Security scheme Exclusion Criteria: * Child whose guardians are protected by law (guardianship, curatorship, safeguard of justice) * Children whose parents are under 18 years of age * Refusal of parental authority to participate
Where this trial is running
Clermont-Ferrand and 4 other locations
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU Grenoble — Grenoble, France (Not_yet_recruiting)
- Hfme — Lyon, France (Not_yet_recruiting)
- Hopital Croix Rousse — Lyon, France (Not_yet_recruiting)
- CHU Saint Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Maguelonne Pons — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.