NCT01042223

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
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
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2008

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

December 1, 2008

Last Update Submit

January 31, 2020

Conditions

Complications

Keywords

Factors Predisposing or Causing

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:

  • 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, 22007, Kuwait

Location

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

December 1, 2008

First Posted

January 5, 2010

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)