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Laryngomalacia Exposed

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042223
First Posted: January 5, 2010
Last Update Posted: July 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boushahri Clinic Medical Center
  Purpose
Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of stridor in infants and children. Symptoms usually appear within the first 2 weeks of life. Its severity increases up to 6 months. 15-60% of infants with laryngomalacia have synchronous airway anomalies.

Condition
Complications

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Laryngomalacia Exposed

Resource links provided by NLM:


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)
Detailed Description:
The most common health complications associated with laryngomalacia were: 1. Gastroesophageal reflux which was presented by arching, choking, gagging, feeding aversion and continuous crying 2. Frequent unilateral eye infections 3. Repeated choking, frequent vomiting and poor weight gain 4. Repeated upper respiratory tract infections (viral and bacterial), coughing and cyanosis 5. Repeated secretory otitis media 6. Aspiration pneumonia
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary care clinics
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042223


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

Responsible Party: Medical Director, Dr Mohamed Said EL-Sayed
ClinicalTrials.gov Identifier: NCT01042223     History of Changes
Other Study ID Numbers: Boushahri Clinic
First Submitted: December 1, 2008
First Posted: January 5, 2010
Last Update Posted: July 19, 2010
Last Verified: December 2008

Keywords provided by Boushahri Clinic Medical Center:
Factors Predisposing or Causing

Additional relevant MeSH terms:
Laryngomalacia
Cartilage Diseases
Musculoskeletal Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases