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CompletedNCT01339546Updated May 3, 2023

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

An observational study in Otitis Media, Myringotomy Tube Insertion and Skin Rash, sponsored by Pfizer. Completed. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
1
Ages
Up to 5 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • ecologic
  • cross sectional
  • trend analysis
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In context

Otitis Media

241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.

This study's enrollment of 1 is below the median of 150 across 57 observational studies indexed under Otitis Media.

Browse Otitis Media studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 5 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Age over 5 years, no ambulatory visits for the events listed in inclusion criteria

05

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
1 participant (actual)

Groups and cohorts

  • 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

Interventions

  • Otherno intervention
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What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

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Study locations

No study locations are listed for this record.

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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01339546
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Apr 20, 2011
Start date
Jun 9, 2010
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
May 3, 2023

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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