NCT04313933

Brief Summary

Aim of study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Last Updated

March 18, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

March 14, 2020

Last Update Submit

March 17, 2020

Conditions

NECCitrulline

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Citrulline as a marker of intestinal recovery

    1 year

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm neonates admitted to NICU at Ain Shams Unversity Hospitals

You may qualify if:

  • preterm neonates \< 35 weeks Preterm neonates\< 2kg Preterm neonates diagnosed with necrotizing enterocolitis

You may not qualify if:

  • renal dysfunction Inborn error of metabolism Congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams University

Cairo, Egypt

Location

Study Officials

  • Amira Mostafa

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
20 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 18, 2020

Study Start

March 12, 2019

Primary Completion

February 10, 2020

Study Completion

February 15, 2020

Last Updated

March 18, 2020

Record last verified: 2020-02

Locations

EG(1)