Calprotectin Levels in Necrotizing Enterocolitis

November 15, 2024 updated by: Sara EROL, Ankara Yildirim Beyazıt University

A Comparative Study of Serum and Fecal Calprotectin Levels in Necrotizing Enterocolitis

Necrotizing enterocolitis (NEC) is a serious condition that can affect premature babies, leading to complications like intestinal damage and infection. In our study, we measured specific markers (called calprotectin) in blood and stool to understand how severe NEC is and predict outcomes. We found that these markers were higher in babies with more severe NEC (stage 3), especially in those who needed surgery or sadly did not survive. This information can help doctors detect NEC earlier, understand its severity, and make better decisions for treating affected babies.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Newborns admitted to the neonatal intensive care unit (NICU) over a 2-year period, born at or before 32 weeks of gestation with a birth weight of ≤1500 grams, were included in this study.

Description

Inclusion Criteria:

before 32 weeks of gestation with a birth weight of ≤1500 grams

Exclusion Criteria:

Infants whose families did not provide consent and those with congenital anomalies were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Premature infants diagnosed with stage 2 and stage 3 NEC and a matched control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The predictive value of serum and fecal calprotectin levels in necrotising enterocolitis (NEC)
Time Frame: 2 years
The predictive value of serum and fecal calprotectin levels in assessing NEC severity (stage 2 and stage 3), intestinal perforation, the need for surgery, and mortality.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Investigators

  • Study Director: Abdullah Kurt, Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26379996/26, 03-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

The IPD and supporting information will be available starting 6 months after the publication of the study results and will remain one year.

IPD Sharing Access Criteria

Access to IPD and supporting information will be available to qualified researchers affiliated with academic or medical institutions. They will be able to access study protocol through a formal data-sharing agreement. Requests must be submitted via email to [sarasurmeli@gmail.com]

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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