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CompletedNCT06693154Updated Nov 18, 2024

Calprotectin Levels in Necrotizing Enterocolitis

An observational study in Necrotising Enterocolitis Neonatal, sponsored by Ankara Yildirim Beyazıt University. Completed at 1 site in Turkey. Open to participants aged 3 Days to 30 Days. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by Ankara Yildirim Beyazıt University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
59
Ages
3 Days to 30 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Necrotising Enterocolitis Neonatal

Keywords

  • calprotectin
  • necrotising enterocolitis
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's enrollment of 59 is below the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 241 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Days to 30 Days
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
59 participants (actual)
Target follow-up
59 Days
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Premature infants diagnosed with stage 2 and stage 3 NEC and a matched control group.
06

What researchers measure

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.

    Time frame: 2 years

07

Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: 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]

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Jan 2024, 19 months.

Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2024
First posted
Nov 18, 2024
StartActual
Jun 1, 2022
Primary completionActual
Jan 1, 2024
CompletionActual
Jun 1, 2024
Last update
Nov 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06693154
Responsible party
Sara EROL (Assoc Prof, MD, Ankara Yildirim Beyazıt University) — Principal investigator
First posted
Nov 18, 2024
Start date
Jun 1, 2022
Primary completion
Jan 1, 2024
Completion
Jun 1, 2024
Last update
Nov 18, 2024

Study contacts

Abdullah Kurt
study director · Ankara Yildirim Beyazıt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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