Laryngomalacia Exposed

NCT ID: NCT01042223

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

14 Days

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boushahri Clinic Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Said El-Sayed

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed S EL-Sayed, MBBCh, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

New Children's Hospital, Cairo University

Locations

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Boushahri Clinic Medical Center

Kuwait City, P.O.Box :698 Salmiya, Kuwait

Site Status

Countries

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Kuwait

Other Identifiers

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Boushahri Clinic

Identifier Type: -

Identifier Source: org_study_id

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