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

April 28, 2023 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

National Ambulalatory Medical Care Survey (NAMCS)-national sample of visits to non federally employed office based physicians who are primarily engaged in direct patient care, and National Hospital Ambulatory Medical Care Survey (NHAMCS)- national sample of visits to emergency and outpatient departments and to ambulatory surgery facilities in noninstitutional general and short stay hospitals, exclusive of Federal, military, and Veterans Administration hospitals, located in the 50 States and the District of Columbia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study population
All ambulatory visits for otitis media, myringotomy tube insertion, skin rash or trauma among children age 5 or under during the periods of study
Other: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 1) 2001-2009 inclusive (9 years) and 2) 2011-2013 inclusive (3 years)
1) 2001-2009 inclusive (9 years) and 2) 2011-2013 inclusive (3 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs)
1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs)
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
Time Frame: 1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs)
1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs)
Change in ambulatory care visit rates for rash between 2001-09 to 2011 -13 among children less than 5 years old. (Timeframes are retrospective)
Time Frame: 1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs)
1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs)
Change in ambulatory care visit rates for trauma between 2001-09 to 2011-13 among children less than 5 years old. (Timeframes are retrospective)
Time Frame: 1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs)
1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2010

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6096A1-4018
  • B1851041 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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