Discovering Laryngomalacia
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Purpose
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 |
|---|
|
Laryngomalacia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Discovering Laryngomalacia |
| Enrollment: | 1500 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Laryngomalacia
Patients with Laryngomalacia
|
|
Control Group
Patients without 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.
Eligibility| Ages Eligible for Study: | up to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Primary Care Clinic
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| Kuwait | |
| Boushahri Clinic Medical Center | |
| Kuwait, Kuwait, P.O.Box: 698 Salmiya | |
| Principal Investigator: | Mohamed S EL-Sayed, MBBCh, MSc, MD | New Children's Hospital, Cairo University |
More Information
No publications provided
| Responsible Party: | Medical Director, Dr Mohamed Said EL-Sayed |
| ClinicalTrials.gov Identifier: | NCT01165489 History of Changes |
| Other Study ID Numbers: | Boushahri Medical Center |
| Study First Received: | July 19, 2010 |
| Last Updated: | July 19, 2010 |
| Health Authority: | Kuwait: The Medical Ethics Committee at Boushahri Clinic |
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 |
ClinicalTrials.gov processed this record on June 18, 2013