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Laryngomalacia No Longer An Ambiguity

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ClinicalTrials.gov Identifier: NCT00972764
Recruitment Status : Completed
First Posted : September 7, 2009
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Said El-Sayed, Boushahri Clinic Medical Center

Tracking Information
First Submitted Date September 4, 2009
First Posted Date September 7, 2009
Last Update Posted Date February 5, 2020
Study Start Date January 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Laryngomalacia No Longer An Ambiguity
Official Title Laryngomalacia No Longer An Ambiguity
Brief Summary The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Primary care clinics
Condition Laryngomalacia
Intervention Not Provided
Study Groups/Cohorts
  • Control
  • Laryngomalacia Cases
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September¬†4,¬†2009)
1500
Original Actual Enrollment Same as current
Actual Study Completion Date September 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number NCT00972764
Other Study ID Numbers 461956 (BoushahriCMC)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mohamed Said El-Sayed, Boushahri Clinic Medical Center
Study Sponsor Boushahri Clinic Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Mohamed S EL-Sayed, MBBCh,MSc,MD New Children's Hospital, Cairo University
PRS Account Boushahri Clinic Medical Center
Verification Date January 2020