NCT01165489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
Last Updated

July 20, 2010

Status Verified

December 1, 2009

Enrollment Period

2.5 years

First QC Date

July 19, 2010

Last Update Submit

July 19, 2010

Conditions

Laryngomalacia

Keywords

LaryngomalaciaCongenital AnomaliesAssociated Health Problems

Study Arms (2)

Laryngomalacia

Patients with Laryngomalacia

Control Group

Patients without Laryngomalacia

Eligibility Criteria

Age4 Weeks - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boushahri Clinic Medical Center

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

Location

MeSH Terms

Conditions

LaryngomalaciaCongenital Abnormalities

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesMusculoskeletal AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mohamed S EL-Sayed, MBBCh, MSc, MD

    New Children's Hospital, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 20, 2010

Study Start

January 1, 2007

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

July 20, 2010

Record last verified: 2009-12

Locations

KU(1)