Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 36
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
- Full-term neonates
Neonates with average birth weight
Preterm neonates with major congenital gastrointestinal anomalies or chromosomal abnormalities
Trial population
Preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams admitted to Assiut University Children Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
112 Participants
are grouped into 2 trial groupsGroup A: Exclusively breastfed preterm infants
Group B: Exclusively formula-fed preterm infants
Trial outcomes
Primary outcomes
1
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 lifeSecondary outcomes
1
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 life2
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 life3
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 lifeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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