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

This study is not yet open for participant recruitment.
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02010268
First received: August 2, 2013
Last updated: December 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Enteropathy, Necrotizing Enterocolitis
Other: Collection of stool samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • fecal calprotectin level [ Time Frame: From birth to hospital discharge (3 months maximum). ] [ Designated as safety issue: No ]
    Quantification of fecal calprotectin in stool samples collected every week and the first 3 days during an interruption over 48 hours of enteral feeding


Secondary Outcome Measures:
  • Evaluation of the performance of fecal calprotectin rapid assay. [ Time Frame: from birth to hospital discharge (3 months maximum) ] [ Designated as safety issue: No ]
    The measurement results of fecal calprotectin obtained by the rapid quantitative immunochromatography method, will be compared with those obtained by conventional reference method (ELISA).


Estimated Enrollment: 125
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preterm neonates
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.

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

Ages Eligible for Study:   up to 33 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02010268

Contacts
Contact: Florence Campeotto, MD, PhD +33171196498 florence.campeotto@nck.aphp.fr
Contact: Laurence Lecomte, PhD +33171196494 laurence.lecomte@nck.aphp.fr

Locations
France
Necker Hospital Not yet recruiting
Paris, France, 75015
Contact: Florence Campeotto, MD, PhD    +33 1 71 19 64 98    florence.campeotto@nck.aphp.fr   
Contact: Laurence Lecomte, PhD    +33 1 71 19 64 94    laurence.lecomte@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence Campeotto, MD, PhD Necker Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02010268     History of Changes
Other Study ID Numbers: P111104
Study First Received: August 2, 2013
Last Updated: December 9, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Faecal calprotectin
Feces
Preterm neonates
Enterocolitis
Enteropathy
Necrotizing

Additional relevant MeSH terms:
Enterocolitis
Intestinal Diseases
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014