Use of Faecal Calprotectin to Predict Enteropathy of the Preterm Neonates

Enteropathy, Necrotizing Enterocolitis Clinical Trial

— CALPROPREMA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010268
• Other study ID #: P111104
• Status: Completed
• Phase: N/A
• First received: August 2, 2013
• Last updated: December 20, 2017
• Start date: September 30, 2013
• Est. completion date: February 22, 2015

Study information

• Verified date: December 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 22, 2015
• Est. primary completion date: February 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 33 Months

Eligibility

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.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Enteropathy, Necrotizing Enterocolitis
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Necker Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From birth to hospital discharge (3 months maximum).
Secondary	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).	from birth to hospital discharge (3 months maximum)