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Discovering Laryngomalacia

Sponsor
Boushahri Clinic Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01165489
Collaborator
(none)
1,500
Enrollment
1
Location
32
Duration (Months)
46.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Laryngomalacia is the most common congenital malformation of the larynx. It results from abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of infants with laryngeomalacia have synchronous airway anomalies.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    500 full term babies ≥37 weeks of both sexes delivered by different modes of delivery, with birth weights ≥2.5 kg, no history of natal or post-natal complications and from the same community. Mothers of these babies are from different socioeconomic standards and from the same community. These babies were diagnosed as having laryngomalacia. Clinical, flexible nasal and laryngeal scope, radiological and milk scintiscan were the tools used in our assessment. One thousand full term babies delivered with normal larynx, almost within the same period of time and from the same community were used as a control.

    Laryngomalacia was recognized with significant statistical difference in dacryostenosis, deviated nasal septum, adenoid hypertrophy and gastroesophageal reflux disease. No significant statistical difference in pectus excavatum, cleft lip or palate, congenital lobar emphysema fistula and choanal atresia.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Discovering Laryngomalacia
    Study Start Date :
    Jan 1, 2007
    Actual Primary Completion Date :
    Jul 1, 2009
    Actual Study Completion Date :
    Sep 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Laryngomalacia

    Patients with Laryngomalacia
    Control Group

    Patients without Laryngomalacia

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      4 Weeks to 12 Months
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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.

      Exclusion Criteria:

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Boushahri Clinic Medical Center Kuwait Kuwait P.O.Box: 698 Salmiya

      Sponsors and Collaborators

      • Boushahri Clinic Medical Center

      Investigators

      • Principal Investigator: Mohamed S EL-Sayed, MBBCh, MSc, MD, New Children's Hospital, Cairo University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01165489
      Other Study ID Numbers:
      • Boushahri Medical Center
      First Posted:
      Jul 20, 2010
      Last Update Posted:
      Jul 20, 2010
      Last Verified:
      Dec 1, 2009
      Keywords provided by , ,
      Laryngomalacia
      Congenital Anomalies
      Associated Health Problems
      Additional relevant MeSH terms:
      Laryngomalacia

      Study Results

      No Results Posted as of Jul 20, 2010