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Predictive Diagnosis of Ulcero-Necrotizing EnteroColitis in Premature Babies Using an Artificial Intelligence Approach Based on Early Analysis of the Fecal Microbiota

RecruitingNAAges any - 1 DayAllUniversity Hospital, Clermont-Ferrand
NCT06727877 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Prematurity affects around 7% of births in France. Necrotizing enterocolitis (NEC) is a dreaded digestive complication. It is responsible for a mortality rate ranging from 15 to 40%, a rate that has remained stable in recent years, and for medium- and long-term digestive and neurodevelopmental morbidity. Its onset is unpredictable and sudden, usually between 10 and 20 days of life, and requires immediate, aggressive management: hemodynamic support, fasting, systemic antibiotic therapy or even surgery. Prevention is therefore essential, but systematic measures with proven efficacy (breastfeeding, early enteral feeding, multiple probiotics) are few and far between. What's more, these preventive measures cannot be modulated and adapted individually, since it is not possible to finely predict the risk of developing enterocolitis. Thus, the use of a predictive diagnostic test for NEC would

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📋 Eligibility rules (as published)
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
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What it tests

  • Ability of early digestive microbiota analysis (using artificial intelligence) to predict the occurrence of NEC diagnosed according to the Bell classification.
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Where

5 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU Grenoble
Grenoble, France
HFME
Lyon, France
Hopital Croix Rousse
Lyon, France
CHU Saint Etienne
Saint-Etienne, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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