Discovering Laryngomalacia

NCT ID: NCT01165489

Last Updated: 2010-07-20

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

2007-01-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laryngomalacia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Laryngomalacia

Patients with Laryngomalacia

No interventions assigned to this group

Control Group

Patients without Laryngomalacia

No interventions assigned to this group

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.

Exclusion Criteria

\-
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

12 Months

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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Dr Mohamed Said EL-Sayed

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, , Kuwait

Site Status

Countries

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Kuwait

Other Identifiers

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Boushahri Medical Center

Identifier Type: -

Identifier Source: org_study_id

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