National Trends in Otitis Media in Children Under 5 Years of Age
NCT01339546
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
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1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Otitis Media, Myringotomy Tube Insertion, Skin Rash, Trauma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
Age over 5 years, no ambulatory visits for the events listed in inclusion criteria
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Otitis Media, Myringotomy Tube Insertion, Skin Rash, TraumaNational Trends in Otitis Media in Children Under 5 Years of Age
NCT01339546
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | National Trends in Otitis Media in Children Under 5 Years of Age | |||
| Official Title | National Trends In Ambulatory Care Visits For Otitis Media In Children Under The Age Of Five In The United States | |||
| 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. | |||
| 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 | |||
| Study Design | Observational Model: Ecologic or Community Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| 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 | |||
| Condition |
| |||
| Intervention | Other: no intervention | |||
| Study Groups/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 Intervention: Other: no intervention | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 1 | |||
| Original Estimated Enrollment | 0 | |||
| Actual Study Completion Date | June 30, 2017 | |||
| Actual Primary Completion Date | June 30, 2017 (Final data collection date for primary outcome measure) | |||
| Eligibility 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 | |||
| Sex/Gender | Not Provided | |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01339546 | |||
| Other Study ID Numbers | 6096A1-4018 B1851041 ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2017 | |||