Use of Faecal Calprotectin to Predict Enteropathy of the Preterm Neonates
CALPROPREMA
Evaluation of a Clinico-biological Predictive Score of Enterocolitis and Enteropathy of the Preterm Neonates. Usefulness of the Rapid Assay of the Faecal Calprotectin.
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2013
CompletedStudy Start
First participant enrolled
September 30, 2013
CompletedFirst Posted
Study publicly available on registry
December 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2015
CompletedSeptember 8, 2025
September 1, 2025
1.4 years
August 2, 2013
September 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluation of the performance of fecal calprotectin rapid assay.
from birth to hospital discharge (3 months maximum)
Study Arms (1)
preterm neonates
EXPERIMENTALPreterm neonates (birth before 33 weeks of gestation)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient with a malformation.
- Lack of signature of the consent by parents or holders of parental authority.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necker Hospital
Paris, 75015, France
Related Publications (1)
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.
PMID: 32418251BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florence Campeotto, MD, PhD
Necker Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2013
First Posted
December 12, 2013
Study Start
September 30, 2013
Primary Completion
February 22, 2015
Study Completion
February 22, 2015
Last Updated
September 8, 2025
Record last verified: 2025-09