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

• ClinicalTrials.gov Identifier: NCT01339546
• Recruitment Status: Completed
• First Posted: April 20, 2011
• Last Update Posted: November 24, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Otitis Media; Myringotomy Tube Insertion; Skin Rash; Trauma	Other: no intervention

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 Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• Official Title: National Trends In Ambulatory Care Visits For Otitis Media In Children Under The Age Of Five In The United States
• Actual Study Start Date: June 9, 2010
• Actual Primary Completion Date: June 30, 2017
• Actual Study Completion Date: June 30, 2017

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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) ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01339546 History of Changes
• Other Study ID Numbers: 6096A1-4018; B1851041 ( Other Identifier: Alias Study Number )
• First Posted: April 20, 2011
• Last Update Posted: November 24, 2017
• Last Verified: November 2017

Keywords provided by Pfizer:

ecologic; cross sectional; trend analysis

Additional relevant MeSH terms:

Otitis; Otitis Media; Ear Diseases; Otorhinolaryngologic Diseases