Discovering Laryngomalacia

This study has been completed.
Sponsor:
Information provided by:
Boushahri Clinic Medical Center
ClinicalTrials.gov Identifier:
NCT01165489
First received: July 19, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted

July 19, 2010
July 19, 2010
January 2007
July 2009   (final data collection date for primary outcome measure)
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No Changes Posted
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Discovering Laryngomalacia
Discovering Laryngomalacia

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample

Primary Care Clinic

Laryngomalacia
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  • Laryngomalacia
    Patients with Laryngomalacia
  • Control Group
    Patients without Laryngomalacia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
September 2009
July 2009   (final data collection date for primary outcome measure)

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:

-

Both
up to 12 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Kuwait
 
NCT01165489
Boushahri Medical Center
Yes
Medical Director, Dr Mohamed Said EL-Sayed
Boushahri Clinic Medical Center
Not Provided
Principal Investigator: Mohamed S EL-Sayed, MBBCh, MSc, MD New Children's Hospital, Cairo University
Boushahri Clinic Medical Center
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP