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Comparison · NCT04614974-82391742

Speech Language Therapy Alone vs Speech Language Therapy and Acid Suppression Therapy: Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Speech Language Therapy Alone vs Speech Language Therapy and Acid Suppression Therapy: Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year. Trial comparisons, record NCT04614974-82391742. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04614974-82391742

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.05880.01630.191wilson
Risk in group 20.03230.005720.162wilson
Risk difference, group 1 minus group 20.0266-0.110.161newcombe hybrid score
Risk ratio, group 1 over group 21.820.17419.1log
Odds ratio, group 1 over group 21.880.16221.8log
Number needed to treat, for one more participant with the outcome on Speech Language Therapy Alone than on Speech Language Therapy and Acid Suppression Therapy37.6from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Speech 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.
234OG000
Group 2Speech 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.
131OG001

Outcome

Type
SECONDARY
Title
Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year
Description
The need for escalation of treatment with supraglottoplasty surgery will be assessed through medical chart review up to 1 year.
Time frame
1 year
Population

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

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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