NCT07810543

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026May 2028

First Submitted

Initial submission to the registry

September 3, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2028

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 3, 2026

Last Update Submit

September 8, 2026

Conditions

Necrotizing EnterocolitisPrematureBreast Feeding

Keywords

Fecal calprotectinNecrotizing enterocolitisPreterm infantsBreastfeedingFormula feedingAssiut

Outcome Measures

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.

    Within the first 30 days of life

Secondary Outcomes (3)

  • Comparison of fecal calprotectin between feeding groups

    Within the first 30 days of life

  • Diagnostic performance of fecal calprotectin for NEC

    Within the first 30 days of life

  • Correlation of feeding type with necrotizing enterocolitis

    Within the first 30 days of life

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Full-term neonates
  • Neonates with average birth weight
  • Preterm neonates with major congenital gastrointestinal anomalies or chromosomal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22271701BACKGROUND

  • 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.

    PMID: 26348753BACKGROUND

  • 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.

    PMID: 27515558BACKGROUND

  • Neu J, Walker WA. Necrotizing enterocolitis. N Engl J Med. 2011 Jan 20;364(3):255-64. doi: 10.1056/NEJMra1005408. No abstract available.

    PMID: 21247316BACKGROUND

MeSH Terms

Conditions

Enterocolitis, NecrotizingPremature BirthBreast Feeding

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Nafisa H Refat, prof

    Pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Amany M Hussien, Resident

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 9, 2026

Study Start

September 3, 2026

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

May 10, 2028

Last Updated

September 10, 2026

Record last verified: 2026-09