Plasma Citrulline in Preterm With NEC (NEC)

March 17, 2020 updated by: Amira Mostafa, Ain Shams University
Aim of study

Study Overview

Status

Completed

Conditions

Detailed Description

Introduction

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ainshams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm neonates admitted to NICU at Ain Shams Unversity Hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma citrulline as a marker of Necrotizing enterocolitis diagnosis
Time Frame: 1 Year
Compare plasma citrulline in NEC and comparing it with properly matched healthy neonates
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Citrulline as a marker of intestinal recovery
Time Frame: 1 year
Follow up plasma citrulline level after initiation of feeding
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Amira Mostafa, ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2019

Primary Completion (Actual)

February 10, 2020

Study Completion (Actual)

February 15, 2020

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • FMASU M S 419/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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