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Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

This study is currently recruiting participants.
Verified August 2017 by Alejandro Hoberman, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02567825
First Posted: October 5, 2015
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
George Washington University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Alejandro Hoberman, University of Pittsburgh
  Purpose
To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management will meaningfully improve children's acute otitis media (AOM) experience over the succeeding 2 years.

Condition Intervention Phase
Acute Otitis Media Procedure: Tympanostomy tube placement Procedure: Nonsurgical management Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Subjects in the randomization phase of the study will be randomized to either medical management or tube surgery. No masking will occur.
Primary Purpose: Treatment
Official Title: Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

Resource links provided by NLM:


Further study details as provided by Alejandro Hoberman, University of Pittsburgh:

Primary Outcome Measures:
  • Acute Otitis Media rate [ Time Frame: 2 years ]
    Average number of AOM episodes during the 2-year follow-up period.


Secondary Outcome Measures:
  • Severity of AOM episodes per American Academy of Pediatrics definitions [ Time Frame: 2 years ]
    Comparison of the proportion of AOM recurrences categorized as severe vs. non-severe using the American Academy of Pediatrics definition (severe, indicated by moderate or severe otalgia or temperature ≥39°C vs. non-severe, indicated by mild otalgia or temperature <39°C).

  • Severity of AOM episodes per AOM-Severity of Symptoms Score [ Time Frame: 2 years ]
    Comparison of AOM-Severity of Symptoms scores at Days 1 and Day 5 of AOM recurrences

  • Frequency distribution of AOM recurrences [ Time Frame: 2 years ]
  • Time to first AOM recurrence [ Time Frame: 2 years ]
  • Type of recurrences [ Time Frame: 2 years ]
    Proportion of AOM recurrences presenting with intact bulging tympanic membrane or tube otorrhea

  • Antibiotic utilization [ Time Frame: 2 years ]
    Total days per year subjects receive systemic antimicrobials for AOM

  • Selected adverse events [ Time Frame: 2 years ]
    Proportion of children with selected adverse events (protocol defined diarrhea, diaper dermatitis, chronic otorrhea)

  • Antibiotic resistance of nasopharyngeal pathogens [ Time Frame: 2 years ]
    Secondary endpoints concerning resistance include (1) proportion of children whose nasopharyngeal cultures at randomization are, respectively, either negative for S. pneumoniae and H. influenzae, or positive for penicillin-susceptible pathogens, or positive for one or more penicillin-nonsusceptible pathogens, who subsequently are found on a follow-up nasopharyngeal culture to harbor one or more penicillin-nonsusceptible pathogens; (2) proportion of interim, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered; and (3) for all AOM episodes, the proportions of S. pneumoniae and H. influenzae isolates recovered at a visit during April or May (end of the respiratory season) that are penicillin nonsusceptible.

  • Cost-effectiveness [ Time Frame: 2 years ]
    Greater cost-effectiveness in children at higher-risk for rAOM than in children at lower-risk. Cost effectiveness of each treatment strategy will be calculated by dividing the costs of each strategy by its effectiveness.


Estimated Enrollment: 240
Study Start Date: November 2015
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A- surgical management
Tympanostomy tube placement
Procedure: Tympanostomy tube placement
As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used. Participants will be followed overtime for recurrences of AOM and treated with topical antimicrobials.
Treatment B - nonsurgical management
Nonsurgical management
Procedure: Nonsurgical management
Participants will be followed overtime for recurrences of AOM and treated with systemic antimicrobials.

Detailed Description:
Tympanostomy tube placement (TTP) for recurrent acute otitis media (rAOM) is frequently performed in children under 3 years of age; however, a critical need exists to establish its risk/benefit ratio. Seventy percent of children experience at least one episode of AOM during the first year of life; 20% of children have rAOM. The efficacy of TTP for preventing rAOM, assumedly by maintaining middle-ear ventilation, remains unclear. Benefits of TTP must be balanced against risks of anesthesia, complications and sequelae of surgery, and cost. Accordingly, the objective of this proposal is to determine the efficacy of TTP in children aged 6-35 months, the group in which rAOM is most troublesome. The central hypothesis is that in children with rAOM, the operation will prove effective over the ensuing 2 years overall, but the benefit in a more severely affected, and therefore higher-risk subgroup may be substantially greater than in a less severely affected subgroup, in whom benefits may not outweigh risks. The rationale for this research is based on a belief that the limited nature of the benefit of TTP found in earlier clinical trials may have been the result of enrolling children whose illnesses had not been diagnosed using stringent criteria and/or whose ascertainment of episodes had relied on undocumented histories. The primary objective is to determine the extent to which TTP reduces the overall rate of recurrences in children with rAOM over a 2-year period. In a phase 3 randomized, clinical trial, children aged 6-35 months who are at risk for rAOM will be followed prospectively and examined promptly with new respiratory illnesses to accurately document episodes of AOM. A total of 240 children who meet stringent inclusion criteria for rAOM will be eligible to undergo randomization within strata (age and exposure to other children) to receive TTP or nonsurgical management. Children will be followed for 2 years; the average number of episodes of AOM will be documented and compared between groups. The secondary objective is to determine changes following TTP in nasopharyngeal (NP) colonization with resistant bacteria. At the time of randomization and 3 times a year for 2 years, NP specimens will be obtained and cultured. Susceptibility testing and serotyping will be performed, and the proportions of children colonized with resistant bacteria compared between treatment groups. The tertiary objective is to determine cost-effectiveness of TTP. The investigators will calculate both direct medical and nonmedical costs and correlate this with the number of days that each child has AOM symptoms, otorrhea, and any adverse events or complications. The proposed research is innovative, as the investigators will document AOM episodes prospectively using stringent diagnostic criteria and obtain digital tympanic membrane images otoendoscopically to enhance accuracy of observations. Findings of the proposed study will provide clinicians and parents with dependable evidence concerning the overall effects of TTP compared with nonsurgical management in children with rAOM of varying degrees of severity, enabling evidence-based decisions regarding an important component of the children's healthcare.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. are aged 6-35 months,
  2. have rAOM, defined as the occurrence of 3 AOM episodes in 6 months or 4 episodes in 12 months with ≥1 episode in the preceding 6 months, and
  3. 2 of these AOM episodes have been documented by trained study personnel.

Exclusion Criteria

  1. have a history of TTP,
  2. have a chronic illness (cystic fibrosis, neoplasm, juvenile diabetes, renal or hepatic insufficiency, immune dysfunction, malabsorption, inflammatory bowel disease, severe asthma requiring at least 4 courses of oral corticosteroids during the last 12 months),
  3. are allergic to amoxicillin,
  4. have a congenital anomaly that might increase the risk of recurrences (e.g., cleft palate, Down's syndrome),
  5. have had otitis media effusion for at least 3 months in addition to rAOM, or
  6. have sensorineural hearing loss.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567825


Contacts
Contact: Diana Kearney, RN, CCRC 412-692-6717 diana.kearney@chp.edu
Contact: Jennifer Nagg, RN 412-692-8586 jennifer.nagg@chp.edu

Locations
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Radhika Joshi    202-476-4622    rjoshi@childrensnational.org   
Principal Investigator: Diego Preciado, MD         
United States, New York
Legacy Pediatrics Not yet recruiting
Rochester, New York, United States, 14618
Contact: Janet Casey, MD       research.legacypeds@gmail.com   
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Alejandro Hoberman, MD    412-999-3277    hoberman@chp.edu   
Contact: Diana Kearney, CCRC    412-692-6717    Diana.Kearney@chp.edu   
Principal Investigator: Alejandro Hoberman, MD         
United States, West Virginia
WVU Medicine Pediatric and Adolescent Group Practice Not yet recruiting
Morgantown, West Virginia, United States, 26501
Contact: Michelle Shaffer, CCRP    304-893-1039    mmshaffer@hsc.wvu.edu   
Principal Investigator: Timothy Lefeber, MD         
Sponsors and Collaborators
University of Pittsburgh
George Washington University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Alejandro Hoberman, MD University of Pittsburgh School of Medicine; Children's Hospital of Pittsburgh of UPMC
Principal Investigator: Diego Preciado, MD, PhD George Washington University; Childrens National Medical Center
  More Information

Responsible Party: Alejandro Hoberman, Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02567825     History of Changes
Other Study ID Numbers: PRO15060148
1U01DC013995-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 1, 2015
First Posted: October 5, 2015
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Alejandro Hoberman, University of Pittsburgh:
ear infection
antibiotics
infants
children
pediatrics
tympanostomy tubes

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases