Status:

UNKNOWN

Role of Urinary Claudin-2, Caveolin-1, and EGF as Diagnostic Biomarkers of Necrotizing Enterocolitis in Preterm Neonates

Lead Sponsor:

University of Brawijaya

Conditions:

Enterocolitis, Necrotizing

Infant, Premature

Eligibility:

All Genders

1-28 years

Brief Summary

Our study aims to determine the differences in the concentration of urinary claudin-2, caveolin-1, and epidermal growth factor (EGF) as non-invasive biomarkers in the diagnosis of Necrotizing Enteroco...

Detailed Description

Necrotizing enterocolitis (NEC) is a multifactorial syndrome of acute intestinal ischemic necrosis which is one of the acute intestinal emergencies in neonates with high morbidity and mortality rates ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria of Subjects:
  • Premature neonates with 28-34 weeks' gestational age
  • Admitted in Perinatology Unit, Saiful Anwar General Hospital, Malang
  • Parents/guardians have agreed and signed the informed consent of the study
  • Neonates receive nutrition from breast milk or breast milk predominance
  • NEC was diagnosed using Bell's modification criteria.
  • Inclusion Criteria of Control:
  • Premature neonates with 28-34 weeks' gestational age, admitted in Perinatology Unit, Saiful Anwar General Hospital, Malang. Parents/guardians have agreed and signed the informed consent of the study. Neonates receive nutrition from breast milk or breast milk predominance.
  • Term neonates with 37-42 weeks' gestational age, admitted in Perinatology Unit, Saiful Anwar General Hospital, Malang. Parents/guardians have agreed and signed the informed consent of the study. Neonates receive nutrition from breast milk or breast milk predominance.
  • Exclusion Criteria:
  • Treated neonates who died during the study before the diagnosis of NEC was established
  • Neonates whom require surgery during the study
  • Parents/guardians stated that they were not willing to participate in the study.

Exclusion

    Key Trial Info

    Start Date :

    March 17 2022

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    July 1 2022

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT05335577

    Start Date

    March 17 2022

    End Date

    July 1 2022

    Last Update

    April 19 2022

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Saiful Anwar General Hospital

    Malang, East Java, Indonesia, 65111