Clinical trial NCT02010268: Use of Faecal Calprotectin to Predict Enteropathy of the Preterm Neonates
Official title: Evaluation of a Clinico-biological Predictive Score of Enterocolitis and Enteropathy of the Preterm Neonates. Usefulness of the Rapid Assay of the Faecal Calprotectin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteropathy, Necrotizing Enterocolitis
Keywords: Faecal calprotectin
Feces
Preterm neonates
Enterocolitis
Enteropathy
Necrotizing
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 122
Sex: ALL
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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:

* Patient with a malformation.
* Lack of signature of the consent by parents or holders of parental authority.

Primary outcomes:
measure: fecal calprotectin level
timeFrame: From birth to hospital discharge (3 months maximum).
Secondary outcomes:
measure: Evaluation of the performance of fecal calprotectin rapid assay.
timeFrame: from birth to hospital discharge (3 months maximum)
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Necker Hospital
name: Florence Campeotto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campeotto F, Elie C, Rousseau C, Giuseppi A, Hachem T, Gobalakichenane P, Le Touzey M, de Stefano M, Butel MJ, Kapel N. Faecal calprotectin and gut microbiota do not predict enteropathy in very preterm infants. Acta Paediatr. 2021 Jan;110(1):109-116. doi: 10.1111/apa.15354. Epub 2020 Sep 1.