Use of Faecal Calprotectin to Predict Enteropathy of the Preterm Neonates (CALPROPREMA)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Enteropathy, Necrotizing Enterocolitis

Treatments

Other: Collection of stool samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02010268

P111104

Details and patient eligibility

About

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.

Full description

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).

Enrollment

122 patients

Sex

All

Ages

Under 33 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infants prematurely born at a gestational age of 33 weeks or less (or before the 7th month of pregnancy).
Patient whose parents or holders of parental authority signed an informed consent.

Exclusion criteria