Discovering Laryngomalacia

Laryngomalacia Clinical Trial

Official title:

Discovering Laryngomalacia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165489
• Other study ID #: Boushahri Medical Center
• Status: Completed
• Phase: N/A
• First received: July 19, 2010
• Last updated: July 19, 2010
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: December 2009
• Source: Boushahri Clinic Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kuwait: The Medical Ethics Committee at Boushahri Clinic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Laryngomalacia

Locations

Country	Name	City	State
Kuwait	Boushahri Clinic Medical Center	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Boushahri Clinic Medical Center

Country where clinical trial is conducted

Kuwait,