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

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.

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Key information

Conditions

Necrotizing Enterocolitis Behavior Breast Feeding Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Premature Birth Urogenital Diseases

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.
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.
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amany M Hussien, Resident

CONTACT

[email protected]

+20 10 01286248

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Sep 9, 2026
Registry last updated: Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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