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Plasma Citrulline in Preterm With NEC

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04313933
Collaborator
(none)
60
Enrollment
1
Location
11.2
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of study

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Introduction

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Plasma Citrulline in Preterm With NEC
    Actual Study Start Date :
    Mar 12, 2019
    Actual Primary Completion Date :
    Feb 10, 2020
    Actual Study Completion Date :
    Feb 15, 2020

    Outcome Measures

    Primary Outcome Measures

    1. plasma citrulline as a marker of Necrotizing enterocolitis diagnosis [1 Year]

      Compare plasma citrulline in NEC and comparing it with properly matched healthy neonates

    Secondary Outcome Measures

    1. Citrulline as a marker of intestinal recovery [1 year]

      Follow up plasma citrulline level after initiation of feeding

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 30 Days
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • preterm neonates < 35 weeks Preterm neonates< 2kg Preterm neonates diagnosed with necrotizing enterocolitis
    Exclusion Criteria:
    • renal dysfunction Inborn error of metabolism Congenital malformation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AinShams University Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Study Director: Amira Mostafa, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Mostafa, Principal Investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04313933
    Other Study ID Numbers:
    • FMASU M S 419/2019
    First Posted:
    Mar 18, 2020
    Last Update Posted:
    Mar 18, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 18, 2020