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Laryngomalacia Exposed

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ClinicalTrials.gov Identifier: NCT01042223
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Said El-Sayed, Boushahri Clinic Medical Center

Brief Summary:
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 or disease
Complications

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

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Laryngomalacia Exposed
Study Start Date : January 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

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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.

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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
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Kuwait
Boushahri Clinic Medical Center
Kuwait, P.O.Box :698 Salmiya, Kuwait, 22007
Sponsors and Collaborators
Boushahri Clinic Medical Center
Investigators
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Principal Investigator: Mohamed S EL-Sayed, MBBCh, MSc, MD New Children's Hospital, Cairo University
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Responsible Party: Mohamed Said El-Sayed, Professor, Boushahri Clinic Medical Center
ClinicalTrials.gov Identifier: NCT01042223    
Other Study ID Numbers: Boushahri Clinic
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Keywords provided by Mohamed Said El-Sayed, Boushahri Clinic Medical Center:
Factors Predisposing or Causing
Additional relevant MeSH terms:
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Laryngomalacia
Cartilage Diseases
Musculoskeletal Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases