LaryngomalaciaNCT00972764
Laryngomalacia No Longer An Ambiguity
An observational study of Laryngomalacia, run by Boushahri Clinic Medical Center at 1 site in Kuwait.
Trial summary
The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia. Read more about this study
- Who is it for?
- Ages 14 days to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngomalacia
- How many people
- 1,500 participants
- Where
- 1 siteKuwait
- Study dates
- Jan 2006to Sep 2008
- 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 14 days to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary care clinics
Who may be able to join
- Babies delivered with laryngomalacia with ≥ 37 weeks of gestation
- Delivered with birth weights ≥ 2.5 kg
- No history of natal or post-natal complications
- From the same community
Who cannot join
- Pre-term babies
- History of natal or post-natal complications
Trial locations and contacts
1 site in 1 country.
Kuwait1 site
Boushahri Clinic Medical Center
Kuwait City, P.O.Box :698 Salmiya, 22007
About this study
The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.
Read the detailed description
Laryngomalacia is the most common congenital malformation of the larynx and it is a self-limited disorder. It is the most common cause of stridor in newborns and infants. It results from an abnormal prolapse of supraglottic structures during inspiration. Despite its widespread prevalence, the etiology of laryngomalacia is unclear. Most infants will squeaky but otherwise well. Although affected patients do not exhibit much in the way of other physical symptoms, the unusual voice is worrisome to their parents.
- Conditions
- Laryngomalacia
- Keywords
- Laryngomalacia, Factors Associated or Predisposing
- Medical subject headings
- Laryngomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described | |
| Laryngomalacia Cases | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startJan 2006
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngomalaciaStudies 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boushahri Clinic Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Said El-Sayed, Boushahri Clinic Medical Center
- Investigators
- Mohamed S EL-Sayed, MBBCh,MSc,MD, Principal investigator, New Children's Hospital, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972764
- Sponsor's protocol ID
- 461956 (BoushahriCMC)
- Status last verified
- Jan 2020
- First submitted
- 4 Sep 2009
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngomalacia No Longer An Ambiguity
- ClinicalTrials.gov ID
- NCT00972764
- Acronym / sponsor ID
- 461956 (BoushahriCMC)
- Conditions
- Laryngomalacia
- Keywords
- Laryngomalacia, Factors Associated or Predisposing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Boushahri Clinic Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 Sep 2009 (estimated)
- 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.
The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.
Detailed description
Laryngomalacia is the most common congenital malformation of the larynx and it is a self-limited disorder. It is the most common cause of stridor in newborns and infants. It results from an abnormal prolapse of supraglottic structures during inspiration. Despite its widespread prevalence, the etiology of laryngomalacia is unclear. Most infants will squeaky but otherwise well. Although affected patients do not exhibit much in the way of other physical symptoms, the unusual voice is worrisome to their parents.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| Laryngomalacia Cases | – | – |
Who may qualify
- Ages
- 14 days to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary care clinics
Key inclusion criteria (4 listed)
- Babies delivered with laryngomalacia with ≥ 37 weeks of gestation
- Delivered with birth weights ≥ 2.5 kg
- No history of natal or post-natal complications
- From the same community
Key exclusion criteria (2 listed)
- Pre-term babies
- History of natal or post-natal complications
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
Not reported in the source record.
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 5 Feb 2020.
Related trials for Laryngomalacia
Recruiting
Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases
Laryngomalacia
Not yet recruiting
Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty
Laryngomalacia, Laryngospasm
RecruitingObservational study
Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
Laryngomalacia, Sleep Apnea, Obstructive
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.
Mohamed S EL-Sayed, MBBCh,MSc,MD principal investigator
New Children's Hospital, Cairo 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 Laryngomalacia, run by Boushahri Clinic Medical Center at 1 site in Kuwait.
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 4 inclusion and 2 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 5 Feb 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 Kuwait. 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.
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 5 Feb 2020.