An observational study in Necrotizing Enterocolitis, Premature and Breast Feeding, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 36 Weeks. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Assiut University · Observational
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.
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 112 is below the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams admitted to Assiut University Children Hospital.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preterm infants will be categorized according to feeding type and followed for fecal calprotectin levels and development of necrotizing enterocolitis.
Preterm infants will be categorized according to feeding type and followed for fecal calprotectin levels and development of necrotizing enterocolitis.
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.
Time frame: Within the first 30 days of life
Comparison of fecal calprotectin between feeding groups
Difference in fecal calprotectin levels (µg/g) between exclusively breastfed and exclusively formula-fed preterm infants.
Time frame: 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.
Time frame: 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.
Time frame: Within the first 30 days of life
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
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 planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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