NEC Clinical Trial - Plasma Citrulline in Preterm With NEC NCT04313933

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT04313933
Other study ID #	FMASU M S 419/2019
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	March 12, 2019
Est. completion date	February 15, 2020

Study information
Verified date	February 2020
Source	Ain Shams University
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational [Patient Registry]

Clinical Trial Summary

Aim of study

Description:

Introduction

Recruitment information / eligibility
Status	Completed
Enrollment	60
Est. completion date	February 15, 2020
Est. primary completion date	February 10, 2020
Accepts healthy volunteers
Gender	All
Age group	N/A to 30 Days
Eligibility	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 Design

Related Conditions & MeSH terms

Locations
Country	Name	City	State
Egypt	AinShams University	Cairo

Sponsors *(1)*
Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	plasma citrulline as a marker of Necrotizing enterocolitis diagnosis	Compare plasma citrulline in NEC and comparing it with properly matched healthy neonates	1 Year
Secondary	Citrulline as a marker of intestinal recovery	Follow up plasma citrulline level after initiation of feeding	1 year

See also
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