Breath Holding AttackPhase 3NCT03965988
Docosahexaenoic Acid on Breath Holding Spells in Children
A Phase 3 study testing DHA in people with Breath Holding Attack, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
DHA on Breath Holding Spells Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Breath Holding Attack
- What is being tested?
- DHA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with newly diagnosed sprlls
Who cannot join
None listed.
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: Effect of Docosahexaenoic Acid on Breath Holding Spells in Children: A Randomized Controlled Trial
DHA on Breath Holding Spells
Read the detailed description
Effect of DHA on Breath Holding Spells
- Conditions
- Breath Holding Attack
- Being tested
- DHA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHADrug
Also called Docosahexaenoic acid
Docosahexaenoic acid
PlaceboDrug
Also called Placebo oral tablet
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Docosahexaenoic Acid | Experimental | Docosahexaenoic acid Receives: Drug: DHA |
| Placebo drug | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the spells
Number of attacks
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 2018
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breath Holding AttackStudies 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
- 60 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
- Amira Darwish, Lecturer, Principal investigator, Tanta University - Faculty of MedicineAbeer Salamah, MD, Study director, Tanta University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965988
- Sponsor's protocol ID
- breah holding
- 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
Publications
Salamah A, Darwish AH. Docosahexaenoic Acid Plus Piracetam Versus Piracetam Alone for Treatment of Breath-Holding Spells in Children: A Randomized Clinical Trial. Pediatr Neurol. 2023 Nov;148:32-36. doi: 10.1016/j.pediatrneurol.2023.08.003. Epub 2023 Aug 9.
PubMed 37651975
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
- Effect of Docosahexaenoic Acid on Breath Holding Spells in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03965988
- Acronym / sponsor ID
- breah holding
- Conditions
- Breath Holding Attack
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 May 2018 (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.
DHA on Breath Holding Spells
Detailed description
Effect of DHA on Breath Holding Spells
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 |
|---|---|---|
| Docosahexaenoic Acid | Experimental | Drug: DHADocosahexaenoic acid |
| Placebo drug | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with newly diagnosed sprlls
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DHAAlso: Docosahexaenoic acidDocosahexaenoic acid | Drug | Docosahexaenoic Acid |
| PlaceboAlso: Placebo oral tabletPlacebo | Drug | Placebo drug |
Primary outcome
Frequency of the spells
Time frame: 6 months
Number of attacks
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.
- Derived from this study: PubMed 37651975Salamah A, Darwish AH. Docosahexaenoic Acid Plus Piracetam Versus Piracetam Alone for Treatment of Breath-Holding Spells in Children: A Randomized Clinical Trial. Pediatr Neurol. 2023 Nov;148:32-36. doi: 10.1016/j.pediatrneurol.2023.08.003. Epub 2023 Aug 9.
- 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.
Amira Darwish, Lecturer principal investigator
Tanta University - Faculty of Medicine
Abeer Salamah, MD study director
Tanta 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 DHA in people with Breath Holding Attack, 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 0 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?
Frequency of the spells (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03965988, which also lists 1 linked publication.
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.