Laryngomalacia No Longer An Ambiguity

This study has been completed.
Sponsor:
Information provided by:
Boushahri Clinic Medical Center
ClinicalTrials.gov Identifier:
NCT00972764
First received: September 4, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.


Condition
Laryngomalacia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Laryngomalacia No Longer An Ambiguity

Further study details as provided by Boushahri Clinic Medical Center:

Enrollment: 1500
Study Start Date: January 2006
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Laryngomalacia Cases

Detailed Description:

Laryngomalacia is the most common congenital malformation of the larynx and it is a self-limited disorder. It is the most common cause of stridor in newborns and infants. It results from an abnormal prolapse of supraglottic structures during inspiration. Despite its widespread prevalence, the etiology of laryngomalacia is unclear. Most infants will squeaky but otherwise well. Although affected patients do not exhibit much in the way of other physical symptoms, the unusual voice is worrisome to their parents.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary care clinics

Criteria

Inclusion Criteria:

  • Babies delivered with laryngomalacia with ≥ 37 weeks of gestation
  • Delivered with birth weights ≥ 2.5 kg
  • No history of natal or post-natal complications
  • From the same community

Exclusion Criteria:

  • Pre-term babies
  • History of natal or post-natal complications
  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: NCT00972764

Locations
Kuwait
Boushahri Clinic Medical Center
Kuwait, P.O.Box :698 Salmiya, Kuwait, 22007
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, Mohamed Said EL-Sayed
ClinicalTrials.gov Identifier: NCT00972764     History of Changes
Other Study ID Numbers: 461956 (BoushahriCMC)
Study First Received: September 4, 2009
Last Updated: September 4, 2009
Health Authority: Kuwait: The Medical Ethics Committee at Boushahri Clinic

Keywords provided by Boushahri Clinic Medical Center:
Laryngomalacia
Factors Associated or Predisposing

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 24, 2014