Necrotizing EnterocolitisNCT07810543
Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC
An observational study of Necrotizing Enterocolitis and Premature, run by Assiut University.
Trial summary
This prospective observational study aims to evaluate fecal calprotectin levels as an early indicator of necrotizing enterocolitis in preterm infants and to compare levels between breastfed and formula-fed preterm infants at Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Necrotizing Enterocolitis, Premature, Breast Feeding
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2026to 10 May 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams admitted to Assiut University Children Hospital.
Who may be able to join
- - Preterm neonates less than 36 weeks gestational age
- Or low birth weight less than 1500 grams
- Or both
- Written informed consent from parents or legal guardians
Who cannot join
- - Full-term neonates
- Neonates with average birth weight
- Preterm neonates with major congenital gastrointestinal anomalies or chromosomal abnormalities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fecal Calprotectin Level in Breastfed Versus Formula-Fed Preterm Infants as an Early Indicator of Developing Necrotizing Enterocolitis: A One-Year Study
This prospective observational study aims to evaluate fecal calprotectin levels as an early indicator of necrotizing enterocolitis in preterm infants and to compare levels between breastfed and formula-fed preterm infants at Assiut University Children Hospital.
Read the detailed description
Necrotizing enterocolitis (NEC) is a serious gastrointestinal disease in preterm neonates associated with high morbidity and mortality. Early diagnosis remains challenging. Fecal calprotectin is a non-invasive marker of intestinal inflammation that has shown potential as an early indicator of NEC.
This prospective study will include preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams. Fecal calprotectin levels will be measured and compared between exclusively breastfed and formula-fed infants. The association of fecal calprotectin levels with the development of necrotizing enterocolitis will be assessed.
- Conditions
- Necrotizing Enterocolitis, Premature, Breast Feeding
- Keywords
- Fecal calprotectin, Necrotizing enterocolitis, Preterm infants, Breastfeeding, Formula feeding, Assiut
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth, Breast Feeding
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 |
|---|---|---|
| Exclusively breastfed preterm infants | Preterm infants will be categorized according to feeding type and followed for fecal calprotectin levels and development of necrotizing enterocolitis. | |
| Exclusively formula-fed preterm infants | Preterm infants will be categorized according to feeding type and followed for fecal calprotectin levels and development of necrotizing enterocolitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal calprotectin level in relation to necrotizing enterocolitis
Comparison of fecal calprotectin concentrations (µg/g) between preterm infants who develop necrotizing enterocolitis and those who do not.
Measured: Within the first 30 days of life
Secondary outcomes (3)
Comparison of fecal calprotectin between feeding groups
Difference in fecal calprotectin levels (µg/g) between exclusively breastfed and exclusively formula-fed preterm infants.
Measured: Within the first 30 days of life
Diagnostic performance of fecal calprotectin for NEC
Sensitivity, specificity, and optimal cutoff value of fecal calprotectin for predicting necrotizing enterocolitis using ROC curve analysis.
Measured: Within the first 30 days of life
Correlation of feeding type with necrotizing enterocolitis
Odds ratio for the occurrence of necrotizing enterocolitis according to type of feeding (exclusively breastfed versus exclusively formula-fed), using logistic regression analysis.
Measured: Within the first 30 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start3 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion10 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohamed Esmat Ahmed Hussien, Assiut University
- Investigators
- Nafisa H Refat, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810543
- Sponsor's protocol ID
- FC-NEC-Preterm-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yee WH, Soraisham AS, Shah VS, Aziz K, Yoon W, Lee SK; Canadian Neonatal Network. Incidence and timing of presentation of necrotizing enterocolitis in preterm infants. Pediatrics. 2012 Feb;129(2):e298-304. doi: 10.1542/peds.2011-2022. Epub 2012 Jan 23.
PubMed 22271701Stoll BJ, Hansen NI, Bell EF, Walsh MC, Carlo WA, Shankaran S, Laptook AR, Sanchez PJ, Van Meurs KP, Wyckoff M, Das A, Hale EC, Ball MB, Newman NS, Schibler K, Poindexter BB, Kennedy KA, Cotten CM, Watterberg KL, D'Angio CT, DeMauro SB, Truog WE, Devaskar U, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA. 2015 Sep 8;314(10):1039-51. doi: 10.1001/jama.2015.10244.
PubMed 26348753Fentz HN, Trillingsgaard T. Checking up on Couples-A Meta-Analysis of the Effect of Assessment and Feedback on Marital Functioning and Individual Mental Health in Couples. J Marital Fam Ther. 2017 Jan;43(1):31-50. doi: 10.1111/jmft.12185. Epub 2016 Aug 12.
PubMed 27515558Neu J, Walker WA. Necrotizing enterocolitis. N Engl J Med. 2011 Jan 20;364(3):255-64. doi: 10.1056/NEJMra1005408. No abstract available.
PubMed 21247316
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Calprotectin Level in Breastfed Versus Formula-Fed Preterm Infants as an Early Indicator of Developing Necrotizing Enterocolitis: A One-Year Study
- ClinicalTrials.gov ID
- NCT07810543
- Acronym / sponsor ID
- FC-NEC-Preterm-Assiut-2026
- Conditions
- Necrotizing Enterocolitis, Premature, Breast Feeding
- Keywords
- Fecal calprotectin, Necrotizing enterocolitis, Preterm infants, Breastfeeding, Formula feeding, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 10 May 2028 (estimated)
- First posted
- 9 Sep 2026 (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.
This prospective observational study aims to evaluate fecal calprotectin levels as an early indicator of necrotizing enterocolitis in preterm infants and to compare levels between breastfed and formula-fed preterm infants at Assiut University Children Hospital.
Detailed description
Necrotizing enterocolitis (NEC) is a serious gastrointestinal disease in preterm neonates associated with high morbidity and mortality. Early diagnosis remains challenging. Fecal calprotectin is a non-invasive marker of intestinal inflammation that has shown potential as an early indicator of NEC.
This prospective study will include preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams. Fecal calprotectin levels will be measured and compared between exclusively breastfed and formula-fed infants. The association of fecal calprotectin levels with the development of necrotizing enterocolitis will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusively breastfed preterm infants | – | –Preterm infants will be categorized according to feeding type and followed for fecal calprotectin levels and development of necrotizing enterocolitis. |
| Exclusively formula-fed preterm infants | – | –Preterm infants will be categorized according to feeding type and followed for fecal calprotectin levels and development of necrotizing enterocolitis. |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams admitted to Assiut University Children Hospital.
Key inclusion criteria (4 listed)
- - Preterm neonates less than 36 weeks gestational age
- Or low birth weight less than 1500 grams
- Or both
- Written informed consent from parents or legal guardians
Key exclusion criteria (3 listed)
- - Full-term neonates
- Neonates with average birth weight
- Preterm neonates with major congenital gastrointestinal anomalies or chromosomal abnormalities
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
Fecal calprotectin level in relation to necrotizing enterocolitis
Time frame: Within the first 30 days of life
Comparison of fecal calprotectin concentrations (µg/g) between preterm infants who develop necrotizing enterocolitis and those who do not.
3 secondary outcomes
Comparison of fecal calprotectin between feeding groups
Time frame: Within the first 30 days of life
Diagnostic performance of fecal calprotectin for NEC
Time frame: Within the first 30 days of life
Correlation of feeding type with necrotizing enterocolitis
Time frame: Within the first 30 days of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 22271701Yee WH, Soraisham AS, Shah VS, Aziz K, Yoon W, Lee SK; Canadian Neonatal Network. Incidence and timing of presentation of necrotizing enterocolitis in preterm infants. Pediatrics. 2012 Feb;129(2):e298-304. doi: 10.1542/peds.2011-2022. Epub 2012 Jan 23.
- Background: PubMed 26348753Stoll BJ, Hansen NI, Bell EF, Walsh MC, Carlo WA, Shankaran S, Laptook AR, Sanchez PJ, Van Meurs KP, Wyckoff M, Das A, Hale EC, Ball MB, Newman NS, Schibler K, Poindexter BB, Kennedy KA, Cotten CM, Watterberg KL, D'Angio CT, DeMauro SB, Truog WE, Devaskar U, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA. 2015 Sep 8;314(10):1039-51. doi: 10.1001/jama.2015.10244.
- Background: PubMed 27515558Fentz HN, Trillingsgaard T. Checking up on Couples-A Meta-Analysis of the Effect of Assessment and Feedback on Marital Functioning and Individual Mental Health in Couples. J Marital Fam Ther. 2017 Jan;43(1):31-50. doi: 10.1111/jmft.12185. Epub 2016 Aug 12.
- Background: PubMed 21247316Neu J, Walker WA. Necrotizing enterocolitis. N Engl J Med. 2011 Jan 20;364(3):255-64. doi: 10.1056/NEJMra1005408. No abstract available.
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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.
Nafisa H Refat, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis and Premature, run by Assiut University.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amany M Hussien, Resident (+20 10 01286248, Amani.18313375@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal calprotectin level in relation to necrotizing enterocolitis (time frame: Within the first 30 days of life). 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 NCT07810543, which also lists 4 linked publications.
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 10 Sep 2026.