Trial · NCT02567825
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
NCT02567825, Not applicable, Completed, Alejandro Hoberman; results first posted 2021-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media. Trials, record NCT02567825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02567825
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
- NCT number
- NCT02567825
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 250 participants, actual
- Lead sponsor
- Alejandro Hoberman
- Conditions
- Acute Otitis Media
- Interventions
- Tympanostomy tube placement, Amoxicillin-Clavulanate and/or Ceftriaxone, Ofloxacin Otic
- First posted
- 2015-10-05
- Last updated
- 2022-07-15
- Results first posted
- 2021-12-10
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year | Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed. | An episode of AOM is considered a discrete occurrence if symptoms and signs persisted for, or recurred, 17 or more days after the start of antimicrobial treatment. The rate is calculated by dividing the total number of occurrences by the total number of years of follow-up. Multiple imputation was used when follow-up was incomplete. |
| Secondary | The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment | Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed. | An episode of AOM is considered a discrete occurrence if symptoms and signs persisted for, or recurred, \>=17 days after the start of antimicrobial treatment. The rate is calculated by dividing the total # of occurrences by the total # of years of follow-up. Risk of recurrences was based on early age of onset of AOM; numerous and/or frequent previous AOM episodes; receipt of multiple courses of antibiotic; eligibility for enrollment first evident during warm-weather months; parental characterization of previous AOM episodes as severe; eligibility for enrollment despite nonexposure to other young children; moderate or marked tympanic membrane (TM) bulging with previous AOM episodes; most previous AOM episodes in both ears; and a high score on the Acute Otitis Media Severity of Symptom scale (with scores ranging from 0 to 10 and higher scores indicating greater severity of symptoms) during screening and/or at enrollment. Multiple imputation was used when follow-up was incomplete. |
| Secondary | The Frequency Distribution of AOM Episodes Among Children Completing the Study | Day 1 until Day 786. For children completing the study, the mean length of follow-up was 726 days. | An episode of AOM is considered a discrete occurrence if symptoms and signs persisted for, or recurred, 17 or more days after the start of antimicrobial treatment. Children with at least 23 months of follow-up were considered to have completed the study. |
| Secondary | The Distribution of Children Experiencing Treatment Failure (TF) | Day 1 until Day 786. | Parents used the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale (version 4.0) to rate each of 5 symptoms as none, a little, or a lot, with corresponding scores of 0, 1, and 2. Total scores range from 0 to 10; higher scores indicate greater severity of symptoms. AOM episodes were categorized as likely severe if the parent described the child as having moderate or severe otalgia (a lot of ear tugging), temperature ≥39°C, or an AOM-SOS scale score \>6 Day 1 of the episode. TF is defined as frequent AOM recurrences (2 in 3 months, 3 in 6 or 4 in 12); ≥3 likely severe AOM recurrences, receipt of ≥45 cumulative days of systemic antimicrobial treatment for AOM, otorrhea for ≥45 cumulative days or diarrhea associated with antimicrobial treatment for ≥30 cumulative days, respectively, in 12 months; persistent effusion for ≥12 successive months; TM perforation for ≥90 days; AOM related hospitalization; anesthesia reactions; and tubes in children randomized to nonsurgical management. |
| Secondary | The Time to the First Episode of AOM | Day 1 until Day 786. The mean length of follow-up was 662 days / 21.8 months. | The time to the first episode of AOM is defined as the time, expressed in months, from randomization until the first episode of AOM. |
| Secondary | The Distribution of AOM Episodes Categorized as Probably Severe or Probably Nonsevere | Day 1 until Day 786. | The American Academy of Pediatrics clinical practice guideline concerning the management of AOM refers to children with "severe signs or symptoms" as those with "moderate or severe otalgia or otalgia for \>= 48 hours or temperature 39°C (102.2°F) or higher." To simulate that definition, scores are used from the 5-item Acute Otitis Media Severity of Symptoms (AOM-SOS) scale (version 4.0) in which parents are asked to rate symptoms, as compared with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2. Total scores range from 0 to 10, with higher scores indicating greater severity of symptoms. AOM episodes are categorized as "probably severe" if the parent described the child as having had moderate or severe otalgia (a lot of ear tugging; i.e. a score of 2), temperature \>=39°C, or an AOM-SOS scale score \>6 on Day 1 of the episode. If not "probably severe", then the episode is categorized as "probably nonsevere". |
| Secondary | The Distribution of AOM Episodes Presenting With Tympanic Membrane Bulging or Otorrhea | Day 1 until Day 786. | The presence of either tympanic membrane bulging or tympanic membrane perforation with purulent otorrhea, in addition to documentation of symptoms, is required for each episode of AOM. |
| Secondary | The Mean Days Per Year Children Experience Tube Otorrhea | Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years. | Adverse events, including tube-associated otorrhea, were collected from enrollment through the end of study. Each study visit included a review of adverse events. Any such event that occurred since the previous visit was recorded, including the date of onset and the date of resolution. For each child, the days per year of tube otorrhea is calculated by dividing the total number of days of tube otorrhea (based on dates of onset and resolution) by the total number of years of follow-up. |
| Secondary | The Mean Days Per Year Children Experience AOM Symptoms With an Intact Tympanic Membrane (TM) | Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years. | For a given child, if a day of follow-up coincides with a study visit, the status of the right and left TMs are recorded at the ear exam. If a day of follow-up does not coincide with a study visit the status of each TM is assumed to be the same as the status on the prior day. Scores are used from the 5-item Acute Otitis Media Severity of Symptoms (AOM-SOS) scale (version 4.0) in which parents are asked to rate symptoms, as compared with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2. Total scores range from 0 to 10, with higher scores indicating greater severity of symptoms. Scores are recorded at study visits and on diaries. The total number of days with an intact TM and a AOM-SOS score greater than or equal to 1 is divided by the total number of years of follow-up to arrive at the days per year with AOM symptoms and an intact TM. |
| Secondary | The Mean Days Per Year Children Receive Systemic Antimicrobials for AOM | Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years. | Systemic antibiotics include Amoxicillin-Clavulanate, Ceftriaxone, Cefdinir, Amoxicillin, Azithromycin, Clindamycin, Levofloxacin, Bactrim, Cefprozil, Omnicef and Trimethoprim-Sulfamethoxazole. The days per year, for each child, is calculated by dividing the total number of days the child receives systemic antimicrobials for AOM (based on the recorded start and stop dates) by the total number of years of follow-up. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year | Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed. | The analysis was intention-to-treat (ITT). The participants are randomized children. For each child with incomplete 2-year follow-up, the total number of episodes of acute otitis media were imputed using multivariate imputation by chained equations with 50 imputations. | Occurrences per child-year | MEAN |
| SECONDARY | The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment | Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed. | The analysis was ITT. The participants are randomized children. For each child with incomplete 2-year follow-up, the total number of episodes of acute otitis media were imputed using multivariate imputation by chained equations with 50 imputations. | Occurrences per child-year | MEAN |
| SECONDARY | The Frequency Distribution of AOM Episodes Among Children Completing the Study | Day 1 until Day 786. For children completing the study, the mean length of follow-up was 726 days. | The analysis was ITT. The participants are randomized children having follow-up greater than or equal to 23 months. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Children Experiencing Treatment Failure (TF) | Day 1 until Day 786. | The analysis was ITT. The participants are randomized children with follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Time to the First Episode of AOM | Day 1 until Day 786. The mean length of follow-up was 662 days / 21.8 months. | The analysis was ITT. The participants are randomized children. | Months | MEDIAN |
| SECONDARY | The Distribution of AOM Episodes Categorized as Probably Severe or Probably Nonsevere | Day 1 until Day 786. | The analysis was ITT. The participants are randomized children having at least one episode of AOM. | Episodes of AOM | COUNT_OF_UNITS |
| SECONDARY | The Distribution of AOM Episodes Presenting With Tympanic Membrane Bulging or Otorrhea | Day 1 until Day 786. | The analysis was ITT. The participants are randomized children having at least one episode of AOM. | Episodes of AOM | COUNT_OF_UNITS |
| SECONDARY | The Mean Days Per Year Children Experience Tube Otorrhea | Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years. | The analysis was ITT. The participants are randomized children. | Days per year | MEAN |
| SECONDARY | The Mean Days Per Year Children Experience AOM Symptoms With an Intact Tympanic Membrane (TM) | Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years. | The analysis was ITT. The participants are randomized children. | Days per year | MEAN |
| SECONDARY | The Mean Days Per Year Children Receive Systemic Antimicrobials for AOM | Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years. | The analysis was ITT. The participants are randomized children. | Days per year | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year | Surgical Management | 1.48 | Standard Error .08 | Occurrences per child-year | |
| The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year | Non-Surgical Management | 1.56 | Standard Error .08 | Occurrences per child-year | |
| The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment | Surgical Management | Children considered at low risk of AOM recurrence | 1.28 | Standard Error 0.10 | Occurrences per child-year |
| The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment | Non-Surgical Management | Children considered at low risk of AOM recurrence | 1.56 | Standard Error 0.10 | Occurrences per child-year |
| The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment | Surgical Management | Children considered at high risk of AOM recurrence | 1.67 | Standard Error 0.11 | Occurrences per child-year |
| The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment | Non-Surgical Management | Children considered at high risk of AOM recurrence | 1.56 | Standard Error 0.13 | Occurrences per child-year |
| The Frequency Distribution of AOM Episodes Among Children Completing the Study | Surgical Management | Number of cumulative episodes = 0 | 17 | Participants | |
| The Frequency Distribution of AOM Episodes Among Children Completing the Study | Non-Surgical Management | Number of cumulative episodes = 0 | 12 | Participants | |
| The Frequency Distribution of AOM Episodes Among Children Completing the Study | Surgical Management | Number of cumulative episodes = 1 or 2 | 41 | Participants | |
| The Frequency Distribution of AOM Episodes Among Children Completing the Study | Non-Surgical Management | Number of cumulative episodes = 1 or 2 | 41 | Participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Surgical Management | 129 | |
| Overall Study | STARTED | Non-Surgical Management | 121 | |
| Overall Study | COMPLETED | Surgical Management | 108 | |
| Overall Study | COMPLETED | Non-Surgical Management | 100 | |
| Overall Study | NOT COMPLETED | Surgical Management | 21 | |
| Overall Study | NOT COMPLETED | Non-Surgical Management | 21 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Protocol-defined Diarrhea | Gastrointestinal disorders | Surgical Management | 21 | 129 | 43 |
| other | Protocol-defined Diarrhea | Gastrointestinal disorders | Non-Surgical Management | 34 | 121 | 59 |
| other | Diaper dermatitis | Skin and subcutaneous tissue disorders | Surgical Management | 25 | 129 | 46 |
| other | Diaper dermatitis | Skin and subcutaneous tissue disorders | Non-Surgical Management | 33 | 121 | 56 |
| other | Tube otorrhea | Ear and labyrinth disorders | Surgical Management | 94 | 129 | 320 |
| other | Tube otorrhea | Ear and labyrinth disorders | Non-Surgical Management | 34 | 121 | 119 |
| other | Otorrhea, not tube associated | Ear and labyrinth disorders | Surgical Management | 0 | 129 | 0 |
| other | Otorrhea, not tube associated | Ear and labyrinth disorders | Non-Surgical Management | 8 | 121 | 8 |
| other | Refractory tube otorrhea | Ear and labyrinth disorders | Surgical Management | 3 | 129 | 4 |
| other | Refractory tube otorrhea | Ear and labyrinth disorders | Non-Surgical Management | 2 | 121 | 2 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Surgical Management | 0 | 129 |
| Total, all-cause mortality | Non-Surgical Management | 0 | 121 |
| Total, other adverse events | Surgical Management | 98 | 129 |
| Total, other adverse events | Non-Surgical Management | 70 | 121 |
| Total, serious adverse events | Surgical Management | 3 | 129 |
| Total, serious adverse events | Non-Surgical Management | 7 | 121 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DC013995 | Efficacy of Tympanostomy Tubes for Children with Recurrent Acute Otitis Media | HOBERMAN, ALEJANDRO; PRECIADO, DIEGO | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2015 to 2019 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Surgical Management vs Non-Surgical Management: deaths from any cause | Trial comparisons |
| Surgical Management vs Non-Surgical Management: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02567825/registered?page=2