Necrotising Enterocolitis NeonatalNCT06693154
Calprotectin Levels in Necrotizing Enterocolitis
An observational study of Necrotising Enterocolitis Neonatal, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 30 days
- Conditions the study is for
- Necrotising Enterocolitis Neonatal
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Jun 2024
- How long will I take part?
- 59 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 30 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- before 32 weeks of gestation with a birth weight of ≤1500 grams
Who cannot join
- Infants whose families did not provide consent and those with congenital anomalies were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Necrotising Enterocolitis Neonatal
- Keywords
- calprotectin, necrotising enterocolitis
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Premature infants diagnosed with stage 2 and stage 3 NEC and a matched control group. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jun 2022
- Primary completion1 Jan 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotising Enterocolitis NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
- Target duration
- 59 Days
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara EROL, Ankara Yildirim Beyazıt University
- Investigators
- Abdullah Kurt, Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693154
- Sponsor's protocol ID
- 26379996/26, 03-2022
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40784368
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Serum and Fecal Calprotectin Levels in Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT06693154
- Acronym / sponsor ID
- 26379996/26, 03-2022
- Conditions
- Necrotising Enterocolitis Neonatal
- Keywords
- calprotectin, necrotising enterocolitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 59 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature infants diagnosed with stage 2 and stage 3 NEC and a matched control group. | – | – |
Who may qualify
- Ages
- 3 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- before 32 weeks of gestation with a birth weight of ≤1500 grams
Key exclusion criteria (1 listed)
- Infants whose families did not provide consent and those with congenital anomalies were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 40784368Erol 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullah Kurt study director
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotising Enterocolitis Neonatal, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive value of serum and fecal calprotectin levels in necrotising enterocolitis (NEC) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06693154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.