National Trends in Otitis Media in Children Under 5 Years of Age

Trauma Clinical Trial

Official title:

National Trends In Ambulatory Care Visits For Otitis Media In Children Under The Age Of Five In The United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339546
• Other study ID #: 6096A1-4018
• Secondary ID: B1851041
• Status: Completed
• Start date: June 9, 2010
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The rationale for this study is to assess the change in ambulatory care visit rates for acute otitis media between the period before (2001-2009) and after the introduction of the 13-valent pneumococcal conjugate vaccine (13vPnC) (2011-2013) among children less than 5 years old in the United States.

Description:

NAMCS-The survey utilizes a three stage sampling design based on (1) probability of selecting a primary sampling unit (PSU) (2) probability of selecting a physician within the PSU and (3) probability of selecting a patient within the physician practice. This last probability is defined to be the exact number of office visits during physician's specified reporting week divided by the number of patient record forms completed. NHAMCS- For producing unbiased national estimate, this survey utilizes four stages (a) Probability of selecting a PSU (b) probability of selecting a hospital with in PSU (c) probability of selecting an emergency department (ED) or outpatient department (OPD) within the hospital (d) probability of selecting a visit within ED or OPD. The overall probability of selection is the product of the probabilities at each stage. The inverse of the overall selection probability is the basic inflation weight.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

Five years of age or under at the time of visit, ambulatory visit for otitis media, myringotomy tube insertion, skin rash or trauma during study period Exclusion Criteria: Age over 5 years, no ambulatory visits for the events listed in inclusion criteria

Related Conditions & MeSH terms

• Exanthema
• Myringotomy Tube Insertion
• Otitis
• Otitis Media
• Skin Rash
• Trauma

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ambulatory care visit rates for acute otitis media between the period before (2001-2009) and after the introduction of the 13vPnC vaccine (2011-2013) among children less than 5 years old		1) 2001-2009 inclusive (9 years) and 2) 2011-2013 inclusive (3 years)
Secondary	Change in ambulatory care visit rates for acute otitis media between: 1) 1997-99 to 2001-09; and 2) between 1997-99 to 2011-13 among children less than 5 years old. (Timeframes are retrospective)		1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs)
Secondary	Change in ambulatory care visit rates for myringotomy tube insertion between: 1) 1997-99 to 2001-09; and 2) between 1997-99 to 2011-13 among children less than 5 years old. (Timeframes are retrospective		1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs)
Secondary	Change in ambulatory care visit rates for rash between 2001-09 to 2011 -13 among children less than 5 years old. (Timeframes are retrospective)		1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs)
Secondary	Change in ambulatory care visit rates for trauma between 2001-09 to 2011-13 among children less than 5 years old. (Timeframes are retrospective)		1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs)

External Links

•   To obtain contact information for a study center near you, click here.