An interventional study of Ability of early digestive microbiota analysis (using artificial intelligence) to predict the occurrence of NEC diagnosed according to the Bell classification. in Necrotizing Enterocolitis (NEC) and Healthy Control, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 5 sites in France. Open to participants aged Up to 1 Day, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
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 make it possible to identify high-risk premature babies and develop personalized preventive measures.
Changes in the digestive microbiota precede the onset of NEC, but it has not been possible to identify a reproducible and reliable microbial signature. As a result, the limited power of microbiota analysis and interpretation means that it cannot be used in practice to predict ECUN.
Our partner team (MEDiS) has developed a bioinformatics chain (RiboTaxa) to obtain the precise structure of complex microbial communities from direct metagenomic sequencing data. Stool samples from international cohorts (1562 samples, 208 preterm infants) were then mined to train a deep neural network and generate a predictive diagnostic test for NEC. In a local study (10 cases and 10 controls), the predictive diagnostic performance of this test was 90%, with the 1ère stool identified as "at risk" preceding NEC by 8 days (extremes 4 - 17 days), and the 2nde by 2 days (extremes 0-7 days). We would now like to test our predictive diagnostic technique on a larger number of premature babies in the AURA region.
1000 children included, 200 children tested (50 NEC - 150 controls)
Systematic collection of stool (excluding meconium) from premature infants up to 21 days of age. Systematic analysis of the first two stools at the MEDiS laboratory: analysis of fecal microbiota by direct metagenomic sequencing (RiboTaxa), coupled with artificial intelligence (deep neural network previously trained on literature data). The test gives us a dichotomous response (yes/no) for each stool.
In the event of discordant analysis between the 2 stools (approximately 35% of cases in our preliminary study), a 3ème stool will be analyzed in order to classify the child as being at risk of NEC or not. The person performing these analyses will not be informed of the child's clinical evolution.
The diagnosis of NEC will be made by the clinician in charge of the child, according to the Bell classification.
Follow-up until return home or transfer to a peripheral center. A telephone call will be made to parents at 3 months of age, to ensure that no NECN has occurred after transfer to a peripheral center.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
diagnosis of NEC according to the Bell classification
Diagnostic Test: Ability of early digestive microbiota analysis (using artificial intelligence) to predict the occurrence of NEC diagnosed according to the Bell classification.
children without diagnosis of NEC
Diagnostic Test: Ability of early digestive microbiota analysis (using artificial intelligence) to predict the occurrence of NEC diagnosed according to the Bell classification.
The test gives us a dichotomous response (yes/no) for each stool. We will systematically analyze two stools per child, and in the event of a discrepancy, we will analyze a third to classify the child as being at risk of NEC or not. The analysis model consists of a deep neural network that has been trained and optimized on data from international cohorts. In a local pilot study (N=20), it enabled accurate prediction for 90% of newborns.
predictive diagnostic of NEC based on artificial intelligence analysis of fecal microbiota
percentage of prediction occurrence of NEC
Time frame: before day 21
predictive diagnostic of NEC as a function of newborn characteristics
percentage of predictive NEC according to newborn characteristics
Time frame: before day 21
caracterization of microbiota in premature babies
measures how many types of species
Time frame: before day 21
caracterization of microbiota in premature babies
percentage of different bacteria
Time frame: before day 21
correlations between fecal microbiota and complications of prematurity (infectious, neurological, neurovegetative)
percentage of different bacteria according to the occurrence or non-occurrence of complications of prematurity (intraventricular hemorrhage, retinopathy, sepsis
Time frame: before day 21
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jun 2027, 26 months after the start.
Of 33 interventional studies with no phase under Enterocolitis, Necrotizing, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's planned 26 months is below that.
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