Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC

Fecal Calprotectin Level in Breastfed Versus Formula-Fed Preterm Infants as an Early Indicator of Developing Necrotizing Enterocolitis: A One-Year Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07810543

Enrollment

112

Registered

2026-09-09

Start date

2026-09-03

Completion date

2028-05-10

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Necrotizing Enterocolitis, Premature

Keywords

Fecal calprotectin, Necrotizing enterocolitis, Preterm infants, Breastfeeding, Formula feeding, Assiut

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 36 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Fecal calprotectin level in relation to necrotizing enterocolitis	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.

Secondary

Measure	Time frame	Description
Comparison of fecal calprotectin between feeding groups	Within the first 30 days of life	Difference in fecal calprotectin levels (µg/g) between exclusively breastfed and exclusively formula-fed preterm infants.
Diagnostic performance of fecal calprotectin for NEC	Within the first 30 days of life	Sensitivity, specificity, and optimal cutoff value of fecal calprotectin for predicting necrotizing enterocolitis using ROC curve analysis.
Correlation of feeding type with necrotizing enterocolitis	Within the first 30 days of life	Odds ratio for the occurrence of necrotizing enterocolitis according to type of feeding (exclusively breastfed versus exclusively formula-fed), using logistic regression analysis.

Contacts

CONTACTAmany M Hussien, Resident

Amani.18313375@med.aun.edu.eg+20 10 01286248

STUDY_CHAIRNafisa H Refat, prof

Pediatrics Department, Assiut University Hospitals

Outcome results