- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01042223
Laryngomalacia Exposed
January 31, 2020 updated by: Mohamed Said El-Sayed, Boushahri Clinic Medical Center
Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of stridor in infants and children.
Symptoms usually appear within the first 2 weeks of life.
Its severity increases up to 6 months.
15-60% of infants with laryngomalacia have synchronous airway anomalies.
Study Overview
Status
Completed
Conditions
Detailed Description
The most common health complications associated with laryngomalacia were: 1. Gastroesophageal reflux which was presented by arching, choking, gagging, feeding aversion and continuous crying 2. Frequent unilateral eye infections 3. Repeated choking, frequent vomiting and poor weight gain 4. Repeated upper respiratory tract infections (viral and bacterial), coughing and cyanosis 5. Repeated secretory otitis media 6.
Aspiration pneumonia
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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P.O.Box :698 Salmiya
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Kuwait, P.O.Box :698 Salmiya, Kuwait, 22007
- Boushahri Clinic Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 weeks to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Primary care clinics
Description
Inclusion Criteria:
- 500 full term babies ≥ 37 weeks of both sexes were delivered by different modes of delivery, with birth weights of ≥ 2.5 kg, with no history of natal complications and from the same community.
- Mothers of these babies are from different socioeconomic standards with different educational levels.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed S EL-Sayed, MBBCh, MSc, MD, New Children's Hospital, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
December 1, 2008
First Submitted That Met QC Criteria
January 4, 2010
First Posted (Estimate)
January 5, 2010
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
January 31, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Boushahri Clinic
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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