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Completed

NCT Number: NCT01339546

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

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.

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Key information

Conditions

Otitis Media Ear Diseases Exanthema Myringotomy Tube Insertion Otitis Otorhinolaryngologic Diseases Skin Diseases Skin Rash Skin and Connective Tissue Diseases Trauma Wounds and Injuries

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2011
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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