Comparison · NCT04614974-sae
Speech Language Therapy Alone vs Speech Language Therapy and Acid Suppression Therapy: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Speech Language Therapy Alone vs Speech Language Therapy and Acid Suppression Therapy: serious adverse events. Trial comparisons, record NCT04614974-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04614974-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0882 | 0.0305 | 0.23 | wilson | |
| Risk in group 2 | 0.0968 | 0.0335 | 0.249 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00854 | -0.171 | 0.146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.912 | 0.199 | 4.19 | log | |
| Odds ratio, group 1 over group 2 | 0.903 | 0.168 | 4.85 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Speech Language Therapy Alone than on Speech Language Therapy and Acid Suppression Therapy | 117 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Speech Language Therapy Alone | Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.~Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing. | 3 | 34 | EG000 |
| Group 2 | Speech Language Therapy and Acid Suppression Therapy | Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.~Famotidine: Famotidine will be prescribed based on patients' weight. Caregivers will purchase this medication and dosage will be given to families in easy-to-understand language.~Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing. | 3 | 31 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 year
Source ClinicalTrials.gov
Trial
- Title
- Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
- NCT number
- NCT04614974
- Phases
- PHASE1, PHASE2
- Conditions
- Laryngomalacia, Gastro Esophageal Reflux
- Interventions
- Famotidine, Speech Language Therapy
- Lead sponsor
- Reema Padia
- Results first posted
- 2025-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04614974?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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