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

Last updated on November 12, 2019

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Study Location
Contact
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
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

NCT01339546
Pfizer
Active, not recruiting
National Trends in Otitis Media in Children Under 5 Years of Age

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Descriptive Information
Brief TitleNational Trends in Otitis Media in Children Under 5 Years of Age
Official TitleNational Trends In Ambulatory Care Visits For Otitis Media In Children Under The Age Of Five In The United States
Brief SummaryThe 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 DescriptionNAMCS-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 TypeObservational
Study DesignObservational Model: Ecologic or Community
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationNational 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
  • Otitis Media
  • Myringotomy Tube Insertion
  • Skin Rash
  • Trauma
InterventionOther: no intervention
Study Groups/CohortsStudy 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 StatusCompleted
Actual Enrollment
 (submitted: December 18, 2012)
1
Original Estimated Enrollment
 (submitted: April 19, 2011)
0
Actual Study Completion DateJune 30, 2017
Actual Primary Completion DateJune 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/GenderNot Provided
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01339546
Other Study ID Numbers6096A1-4018
B1851041 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2017

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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