Laryngomalacia No Longer An Ambiguity

NCT ID: NCT00972764

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

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.

Detailed Description

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Laryngomalacia is the most common congenital malformation of the larynx and it is a self-limited disorder. It is the most common cause of stridor in newborns and infants. It results from an abnormal prolapse of supraglottic structures during inspiration. Despite its widespread prevalence, the etiology of laryngomalacia is unclear. Most infants will squeaky but otherwise well. Although affected patients do not exhibit much in the way of other physical symptoms, the unusual voice is worrisome to their parents.

Conditions

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Laryngomalacia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

No interventions assigned to this group

Laryngomalacia Cases

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Babies delivered with laryngomalacia with ≥ 37 weeks of gestation
* Delivered with birth weights ≥ 2.5 kg
* No history of natal or post-natal complications
* From the same community

Exclusion Criteria

* Pre-term babies
* History of natal or post-natal complications
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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461956 (BoushahriCMC)

Identifier Type: -

Identifier Source: org_study_id

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