NECNECNCT04313933
Plasma Citrulline in Preterm With NEC
An observational study of NEC and Citrulline, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of study Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- NEC, Citrulline
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2019to 15 Feb 2020
- How long will I take part?
- 20 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- Child
Study population: Preterm neonates admitted to NICU at Ain Shams Unversity Hospitals
Who may be able to join
- preterm neonates < 35 weeks Preterm neonates< 2kg Preterm neonates diagnosed with necrotizing enterocolitis
Who cannot join
- renal dysfunction Inborn error of metabolism Congenital malformation
Trial locations and contacts
1 site in 1 country.
About this study
Aim of study
Read the detailed description
Introduction
- Conditions
- NEC, Citrulline
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma citrulline as a marker of Necrotizing enterocolitis diagnosis
Compare plasma citrulline in NEC and comparing it with properly matched healthy neonates
Measured: 1 Year
Secondary outcomes (1)
Citrulline as a marker of intestinal recovery
Follow up plasma citrulline level after initiation of feeding
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start12 Mar 2019
- Primary completion10 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NECStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 20 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mostafa, Ain Shams University
- Investigators
- Amira Mostafa, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313933
- Sponsor's protocol ID
- FMASU M S 419/2019
- Acronym
- NEC
- Status last verified
- Feb 2020
- First submitted
- 14 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Citrulline in Preterm With NEC
- ClinicalTrials.gov ID
- NCT04313933
- Acronym / sponsor ID
- NEC / FMASU M S 419/2019
- Conditions
- NEC, Citrulline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of study
Detailed description
Introduction
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 20 Days
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Age groups
- Child
- Study population
- Preterm neonates admitted to NICU at Ain Shams Unversity Hospitals
Key inclusion criteria (1 listed)
- preterm neonates < 35 weeks Preterm neonates< 2kg Preterm neonates diagnosed with necrotizing enterocolitis
Key exclusion criteria (1 listed)
- renal dysfunction Inborn error of metabolism Congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Citrulline as a marker of intestinal recovery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Related trials for NEC
RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Recurrent Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
RecruitingPhase 2/3
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
Advanced Extrapulmonary Neuroendocrine Carcinoma, Metastatic Extrapulmonary Neuroendocrine Carcinoma
RecruitingPhase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Sarcoma, Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira Mostafa study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NEC and Citrulline, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma citrulline as a marker of Necrotizing enterocolitis diagnosis (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.