Clinical Trials Directory

Trials / Completed

CompletedNCT01165489

Discovering Laryngomalacia

Status
Completed
Phase
Study type
Observational
Enrollment
1,500 (actual)
Sponsor
Boushahri Clinic Medical Center · Academic / Other
Sex
All
Age
4 Weeks – 12 Months
Healthy volunteers
Accepted

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.

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.

Conditions

Timeline

Start date
2007-01-01
Primary completion
2009-07-01
Completion
2009-09-01
First posted
2010-07-20
Last updated
2010-07-20

Locations

1 site across 1 country: Kuwait

Source: ClinicalTrials.gov record NCT01165489. Inclusion in this directory is not an endorsement.