An interventional study of Collection of stool samples in Enteropathy, Necrotizing Enterocolitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged Up to 33 Months. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.
Enteropathy and necrotizing enterocolitis (NEC) are digestive emergencies in premature neonates which represent a major concern for the vital prognosis. It is therefore important to propose a tool for early diagnosis of these intestinal complications in order to avoid extended interruptions of enteral feeding at a period of life where growth (and digestive maturation) is in the foreground. Currently, the diagnosis of digestive impairment is based on classical clinical, biological (CRP, procalcitonin, fecal calprotectin, NFS) and radiological (abdomen without preparation) approaches, which induce on one hand a prolonged interruption of enteral feeding sometimes useless and even harmful for the intestinal maturation and, secondly, the establishment of a parenteral nutrition which is not risk-free. The study propose to dose the fecal calprotectin, a non-invasive marker of digestive inflammation, in order to validate the threshold decision proposed in a pilot study (350 µg/g of feces). Measurement of fecal calprotectin levels will be used as an integrated tool to build a powerful screening score combined to the usual parameters used in routine care for the diagnosis of and enteropathy and necrotizing enterocolitis (NEC) in premature neonates. A cohort of preterm infants born at a gestational age of 33 weeks or less will be included from birth. A stool sample will be collected from the diaper once a week, from birth until discharge from the hospital, and every day during gastrointestinal events (interruption of enteral feeding over 48 hours). The study will evaluate the performance of the rapid assay of fecal calprotectin by quantitative immunochromatography compared to the reference method by enzyme-linked immunosorbent assay (ELISA).
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 122 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Compared within Enterocolitis, Necrotizing, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Intestinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preterm neonates (birth before 33 weeks of gestation)
Other: Collection of stool samples
A stool sample will be collected once a week from birth until discharge from the hospital, and every day during digestive episodes, that is to say during an interruption of enteral nutrition for more than 48 hours.
fecal calprotectin level
Quantification of fecal calprotectin in stool samples collected every week and the first 3 days during an interruption over 48 hours of enteral feeding
Time frame: From birth to hospital discharge (3 months maximum).
Evaluation of the performance of fecal calprotectin rapid assay.
The measurement results of fecal calprotectin obtained by the rapid quantitative immunochromatography method, will be compared with those obtained by conventional reference method (ELISA).
Time frame: from birth to hospital discharge (3 months maximum)
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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