Overview

This trial is active, not recruiting.

Conditions otitis media, myringotomy tube insertion, skin rash, trauma
Treatment no intervention
Sponsor Pfizer
Start date June 2010
End date December 2017
Trial size 1 participant
Trial identifier NCT01339546, 6096A1-4018, B1851041

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective retrospective
Arm
All ambulatory visits for otitis media, myringotomy tube insertion, skin rash or trauma among children age 5 or under during the periods of study
no intervention

Primary Outcomes

Measure
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

Measure
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)
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)
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)
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)

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title National Trends In Ambulatory Care Visits For Otitis Media In Children Under The Age Of Five 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pfizer.