Laryngomalacia No Longer An Ambiguity

January 31, 2020 updated by: Mohamed Said El-Sayed, Boushahri Clinic Medical Center
The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
    • P.O.Box :698 Salmiya
      • Kuwait, P.O.Box :698 Salmiya, Kuwait, 22007
        • Boushahri Clinic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Laryngomalacia Cases

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boushahri Clinic Medical Center

Investigators

  • Principal Investigator: Mohamed S EL-Sayed, MBBCh,MSc,MD, New Children's Hospital, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

September 4, 2009

First Submitted That Met QC Criteria

September 4, 2009

First Posted (ESTIMATE)

September 7, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 461956 (BoushahriCMC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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