Discovering Laryngomalacia

Completed

• Conditions: Laryngomalacia

• Registration Number: NCT01165489
• Lead Sponsor: Boushahri Clinic Medical Center

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.

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2009-12
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Last Update Submitted: 2010-07-19
• Study First Posted: 2010-07-20
• Last Update Posted: 2010-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Boushahri Clinic Medical Center; 🇰🇼 Kuwait, Kuwait