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Discovering Laryngomalacia

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ClinicalTrials.gov Identifier: NCT01165489
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : July 20, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Laryngomalacia is the most common congenital malformation of the larynx. It results from abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of infants with laryngeomalacia have synchronous airway anomalies.

Condition or disease
Laryngomalacia

Detailed Description:

500 full term babies ≥37 weeks of both sexes delivered by different modes of delivery, with birth weights ≥2.5 kg, no history of natal or post-natal complications and from the same community. Mothers of these babies are from different socioeconomic standards and from the same community. These babies were diagnosed as having laryngomalacia. Clinical, flexible nasal and laryngeal scope, radiological and milk scintiscan were the tools used in our assessment. One thousand full term babies delivered with normal larynx, almost within the same period of time and from the same community were used as a control.

Laryngomalacia was recognized with significant statistical difference in dacryostenosis, deviated nasal septum, adenoid hypertrophy and gastroesophageal reflux disease. No significant statistical difference in pectus excavatum, cleft lip or palate, congenital lobar emphysema fistula and choanal atresia.


Study Design

Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Discovering Laryngomalacia
Study Start Date : January 2007
Primary Completion Date : July 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Laryngomalacia
Patients with Laryngomalacia
Control Group
Patients without Laryngomalacia


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic
Criteria

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.

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165489


Locations
Kuwait
Boushahri Clinic Medical Center
Kuwait, Kuwait, P.O.Box: 698 Salmiya
Sponsors and Collaborators
Boushahri Clinic Medical Center
Investigators
Principal Investigator: Mohamed S EL-Sayed, MBBCh, MSc, MD New Children's Hospital, Cairo University
More Information

Responsible Party: Medical Director, Dr Mohamed Said EL-Sayed
ClinicalTrials.gov Identifier: NCT01165489     History of Changes
Other Study ID Numbers: Boushahri Medical Center
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: July 20, 2010
Last Verified: December 2009

Keywords provided by Boushahri Clinic Medical Center:
Laryngomalacia
Congenital Anomalies
Associated Health Problems

Additional relevant MeSH terms:
Laryngomalacia
Cartilage Diseases
Musculoskeletal Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases