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
  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

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical Director, Dr Mohamed Said EL-Sayed
ClinicalTrials.gov Identifier: NCT01042223     History of Changes
Other Study ID Numbers: Boushahri Clinic
Study First Received: December 1, 2008
Last Updated: July 16, 2010
Health Authority: Kuwait: The Medical Ethics Committee at Boushahri Clinic

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

ClinicalTrials.gov processed this record on September 16, 2014