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Laryngomalacia Exposed

This study has been completed.
Sponsor:
Information provided by:
Boushahri Clinic Medical Center
ClinicalTrials.gov Identifier:
NCT01042223
First received: December 1, 2008
Last updated: July 16, 2010
Last verified: December 2008

December 1, 2008
July 16, 2010
January 2006
July 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01042223 on ClinicalTrials.gov Archive Site
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Laryngomalacia Exposed
Laryngomalacia Exposed

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.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Primary care clinics

Complications
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
September 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
up to 2 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kuwait
 
NCT01042223
Boushahri Clinic
Yes
Medical Director, Dr Mohamed Said EL-Sayed
Boushahri Clinic Medical Center
Not Provided
Principal Investigator: Mohamed S EL-Sayed, MBBCh, MSc, MD New Children's Hospital, Cairo University
Boushahri Clinic Medical Center
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP