Calprotectin Levels in Necrotizing Enterocolitis

NCT06693154 | Completed

• 1 other identifier: 26379996/26, 03-2022
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Necrotising Enterocolitis Neonatal

Keywords

calprotectin; necrotising enterocolitis

Outcome Measures

Primary Outcomes (1)

• The predictive value of serum and fecal calprotectin levels in necrotising enterocolitis (NEC)

  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

Study Arms (1)

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

Eligibility Criteria

• Age: 3 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Erol S, Tayman C, Korkut S, Cakir U, Kurt A, Koyuncu I. A comparative study of serum and fecal calprotectin levels in necrotizing enterocolitis. J Pediatr (Rio J). 2025 Sep-Oct;101(5):101428. doi: 10.1016/j.jped.2025.101428. Epub 2025 Aug 21.

  PMID: 40784368 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal and blood samples were collected from each eligible patient and were immediately stored at -20°C until batch analysis.

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Abdullah Kurt

  Ankara Yildirim Beyazıt University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 59 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof, MD

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: June 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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 \[sarasurmeli@gmail.com\]

Locations

TU (1)