Pre-TermPhase 3NCT03966170
Citicoline as Neuroprotector in Preterm
A Phase 3 study testing Citicoline in people with Pre-Term, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Citicoline as neuroprotector in preterm Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Pre-Term
- What is being tested?
- Citicoline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm on CPAP or ventilator
Who cannot join
- Multiple congenital anomalies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam
About this study
Official title: Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial
Citicoline as neuroprotector in preterm
Read the detailed description
Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.
- Conditions
- Pre-Term
- Being tested
- Citicoline, Placebo oral tablet
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDrug
Citicoline as neuroprotector
Placebo oral tabletDrug
placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Citicoline | Experimental | Citicoline as neuroprotector Receives: Drug: Citicoline |
| Placebo drug | Placebo comparator | Placebo Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with affection of the brain
Number of children with affection of the brain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 May 2019
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-TermStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- May R Elsheikh, MD, Principal investigator, Tanta University - Faculty of MedicineAbeer Salamah, MD, Study director, Kafr-Elsheikh University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966170
- Sponsor's protocol ID
- Citicoline
- Status last verified
- May 2019
- First submitted
- 24 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03966170
- Acronym / sponsor ID
- Citicoline
- Conditions
- Pre-Term
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 May 2019 (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.
Citicoline as neuroprotector in preterm
Detailed description
Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citicoline | Experimental | Drug: CiticolineCiticoline as neuroprotector |
| Placebo drug | Placebo comparator | Drug: Placebo oral tabletPlacebo |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm on CPAP or ventilator
Key exclusion criteria (1 listed)
- Multiple congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiticolineCiticoline as neuroprotector | Drug | Citicoline |
| Placebo oral tabletplacebo drug | Drug | Placebo drug |
Primary outcome
Number of children with affection of the brain
Time frame: 6 months
Number of children with affection of the brain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No
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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.
May R Elsheikh, MD principal investigator
Tanta University - Faculty of Medicine
Abeer Salamah, MD study director
Kafr-Elsheikh University - Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Citicoline in people with Pre-Term, run by Sherief Abd-Elsalam 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: looking for participants now, as of the sponsor's last update on 29 May 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children with affection of the brain (time frame: 6 months). 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 29 May 2019.