Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC
September 3, 2026 updated by: Amany Mohamed Esmat Ahmed Hussien, Assiut University
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amany M Hussien, Resident
- Phone Number: +20 10 01286248
- Email: Amani.18313375@med.aun.edu.eg
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
Non-Probability Sample
Study Population
Preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams admitted to Assiut University Children Hospital.
Description
Inclusion Criteria:
- - 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
Exclusion Criteria:
- - Full-term neonates
- Neonates with average birth weight
- Preterm neonates with major congenital gastrointestinal anomalies or chromosomal abnormalities
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 |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within the first 30 days of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of fecal calprotectin between feeding groups
Time Frame: Within the first 30 days of life
|
Difference in fecal calprotectin levels (µg/g) between exclusively breastfed and exclusively formula-fed preterm infants.
|
Within the first 30 days of life
|
|
Diagnostic performance of fecal calprotectin for NEC
Time Frame: Within the first 30 days of life
|
Sensitivity, specificity, and optimal cutoff value of fecal calprotectin for predicting necrotizing enterocolitis using ROC curve analysis.
|
Within the first 30 days of life
|
|
Association of feeding type with NEC
Time Frame: Within the first 30 days of life
|
Association between type of feeding (breast milk versus formula) and the occurrence of necrotizing enterocolitis.
|
Within the first 30 days of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nafisa H Refat, prof, Pediatrics Department, Assiut University Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stoll 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.
- Neu J, Walker WA. Necrotizing enterocolitis. N Engl J Med. 2011 Jan 20;364(3):255-64. doi: 10.1056/NEJMra1005408. No abstract available.
- 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.
- Fentz 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.
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 (Estimated)
September 3, 2026
Primary Completion (Estimated)
September 10, 2027
Study Completion (Estimated)
May 10, 2028
Study Registration Dates
First Submitted
September 3, 2026
First Submitted That Met QC Criteria
September 3, 2026
First Posted (Actual)
September 9, 2026
Study Record Updates
Last Update Posted (Actual)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 3, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Intestinal Diseases
- Obstetric Labor, Premature
- Obstetric Labor Complications
- Pregnancy Complications
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Enterocolitis
- Behavior
- Feeding Behavior
- Premature Birth
- Enterocolitis, Necrotizing
- Breast Feeding
Other Study ID Numbers
- FC-NEC-Preterm-Assiut-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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