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
  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

Resource links provided by NLM:


Further study details as provided by Boushahri Clinic Medical Center:

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
Study Population

Primary Care Clinic

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165489

Locations
Kuwait
Boushahri Clinic Medical Center
Kuwait, Kuwait, P.O.Box: 698 Salmiya
Sponsors and Collaborators
Boushahri Clinic Medical Center
Investigators
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 July 20, 2014