Use of Faecal Calprotectin to Predict Enteropathy of the Preterm Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-02-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Defining the Intestinal Microbiota in Premature Neonates

NCT01102738

Premature Intestinal Microbiota Necrotizing Enterocolitis Late Onset Bloodstream Infection

COMPLETED

Early Predictors of Necrotizing Enterocolitis in Neonates

NCT03210831

Necrotizing Enterocolitis

RECRUITING

Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants

NCT04972734

Necrotizing Enterocolitis Premature Birth

RECRUITING NA

Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants

NCT01062828

Premature Newborn Necrotizing Enterocolitis

TERMINATED

Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

NCT04792918

Necrotising Enterocolitis Late-Onset Neonatal Sepsis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enteropathy, Necrotizing Enterocolitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

preterm neonates

Preterm neonates (birth before 33 weeks of gestation)

Group Type EXPERIMENTAL

Collection of stool samples

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.