NCT00972764

Brief Summary

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

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 2006

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, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2009

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

September 4, 2009

Last Update Submit

January 31, 2020

Conditions

Laryngomalacia

Keywords

LaryngomalaciaFactors Associated or Predisposing

Study Arms (2)

Control

Laryngomalacia Cases

Eligibility Criteria

Age14 Days - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Primary care clinics

You may qualify if:

  • 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

You may not qualify if:

  • Pre-term babies
  • History of natal or post-natal complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boushahri Clinic Medical Center

Kuwait City, P.O.Box :698 Salmiya, 22007, Kuwait

Location

MeSH Terms

Conditions

Laryngomalacia

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesMusculoskeletal AbnormalitiesCongenital 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
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 7, 2009

Study Start

January 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

KU(1)