Trial · NCT04614974
Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
NCT04614974, Phase 1, Phase 2, Terminated, Reema Padia; results first posted 2025-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia. Trials, record NCT04614974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04614974
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
- NCT number
- NCT04614974
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Reema Padia
- Conditions
- Laryngomalacia, Gastro Esophageal Reflux
- Interventions
- Famotidine, Speech Language Therapy
- First posted
- 2020-11-04
- Last updated
- 2025-07-20
- Results first posted
- 2025-07-20
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | 3 months | Score change from pre to post surveys on the Pittsburgh Airway Symptom Score (PASS) questionnaire. The PASS is on a scale from 0-10 with a higher score indicating a worse outcome. This outcome will be assessed at the consult and the 3 month follow-up appointment. |
| Primary | Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | 3 months | Score change from pre to post survey on the I-GERQ-R. There are 12 questions on the surveys on a scale of 0-42. A higher score indicates a worse outcome. Those with a score of \>=16 on this survey at the initial consult are excluded from the study, indicating true gastroesophageal reflux disease (GERD). This outcome will be assessed at the consult and the 3 month follow-up appointment. |
| Primary | Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review | 1 year | Change in prevalence of airway symptoms from consult up to 1 year assessed via electronic medical chart review. Notes from the Department of Otolaryngology will be reviewed which include reported symptoms from caregivers and symptoms seen upon exam. Airway symptoms included periods of apnea, chest wall retractions, cyanosis, stridor, noisy breathing, and increased respiratory rate. |
| Primary | Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart | 1 year | Change in prevalence of dysphagia symptoms from consult up to 1 year assessed via electronic medical chart review. Notes from the Department of Otolaryngology will be reviewed which include reported symptoms from caregivers and symptoms seen upon exam. Dysphagia symptoms included choking, coughing, gagging with feeds and/or emesis after feeds. |
| Secondary | Weight (kg/Month) From Consult up to 1 Year | 1 year | Weight change in kilograms per month assessed from medical chart review from consult up to 1 year |
| Secondary | Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year | 1 year | The need for escalation of treatment with supraglottoplasty surgery will be assessed through medical chart review up to 1 year. |
| Secondary | Number of Participants With the Need for Acid Suppression Therapy Medication (Famotidine) From Speech Language Therapy Alone Group From the Day After the Consult up to 1 Year | 1 year | The speech language therapy alone group will be assessed for the need for a prescription for acid suppression therapy (famotidine) from the day after the consult up to 1 year. |
| Secondary | Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the Consult | At initial consult | All patients will be scoped with a flexible laryngoscopy at the initial consult and the type of laryngomalacia (Types 1-3) will be noted. Participants are reported for each type of laryngomalacia noted at the initial consent. Participants can have more than one type of laryngomalacia. Type 1 is characterized by anterior/medial collapse of supra-arytenoid mucosa. Type 2 is characterized by short aryepiglottic folds. Type 3 is characterized by posterior collapse of epiglottis. None are considered better/worse outcomes. |
| Secondary | Number of Participants With the Need for a Different Acid Suppression Therapy Medication (Other Than Famotidine) From the Day After the Consult up to the 3 Month Follow up Appointment | 3 months | Both groups will be assessed for the need for a different acid suppression therapy medication (other than famotidine) from the day after the consult up to the 3 month follow up appointment. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | 3 months | Follow-up PASS was completed by 20/34 (59%) in the speech language therapy alone group and 20/31 (65%) of the speech language therapy and acid suppression therapy group. | score on a scale | MEDIAN |
| PRIMARY | Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | 3 months | Follow-up I-GERQ-R was completed by 20/34 (59%) in the speech language therapy alone group and 20/31 (65%) of the speech language therapy and acid suppression therapy group. However, 1 participant in the speech language therapy alone group only completed questions 1-6 of the I-GERQ-R and therefore was not included in analysis of total I-GERQ-R scores. | score on scale | MEDIAN |
| PRIMARY | Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review | 1 year | 15 participants in the speech language therapy alone group and 21 participants in the speech language therapy and acid suppression therapy group had a follow-up otolaryngology clinic visit within 1 year of initial consult. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart | 1 year | 15 participants in the speech language therapy alone group and 21 participants in the speech language therapy and acid suppression therapy group had a follow-up otolaryngology clinic visit within 1 year of initial consult. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Weight (kg/Month) From Consult up to 1 Year | 1 year | 20 patients in the speech language therapy alone group and 27 patients in the speech therapy and acid suppression therapy group had weights available in the electronic medical record from at least 1 follow-up appointment with any specialty within 1 year. | kg/month | MEDIAN |
| SECONDARY | Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With the Need for Acid Suppression Therapy Medication (Famotidine) From Speech Language Therapy Alone Group From the Day After the Consult up to 1 Year | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the Consult | At initial consult | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With the Need for a Different Acid Suppression Therapy Medication (Other Than Famotidine) From the Day After the Consult up to the 3 Month Follow up Appointment | 3 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group101
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | Speech Language Therapy Alone | Baseline | 3 | Full Range 2 to 5 | score on a scale |
| Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | Speech Language Therapy and Acid Suppression Therapy | Baseline | 3 | Full Range 1 to 5 | score on a scale |
| Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | Speech Language Therapy Alone | Change from baseline to 3 months | -2 | Full Range -5 to 2 | score on a scale |
| Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | Speech Language Therapy and Acid Suppression Therapy | Change from baseline to 3 months | -1 | Full Range -4 to 1 | score on a scale |
| Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | Speech Language Therapy Alone | Baseline | 12 | Full Range 6 to 15 | score on scale |
| Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | Speech Language Therapy and Acid Suppression Therapy | Baseline | 10 | Full Range 5 to 15 | score on scale |
| Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | Speech Language Therapy Alone | Change from baseline to 3 months | -4 | Full Range -12 to 11 | score on scale |
| Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | Speech Language Therapy and Acid Suppression Therapy | Change from baseline to 3 months | -3 | Full Range -11 to 9 | score on scale |
| Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review | Speech Language Therapy Alone | Apnea / Symptom absent at consult and follow-up | 14 | Participants | |
| Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review | Speech Language Therapy and Acid Suppression Therapy | Apnea / Symptom absent at consult and follow-up | 20 | Participants |
1 to 10 of 101Source ClinicalTrials.gov
See all 101 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Speech Language Therapy Alone | 34 | |
| Overall Study | STARTED | Speech Language Therapy and Acid Suppression Therapy | 31 | |
| Overall Study | COMPLETED | Speech Language Therapy Alone | 20 | |
| Overall Study | COMPLETED | Speech Language Therapy and Acid Suppression Therapy | 20 | |
| Overall Study | NOT COMPLETED | Speech Language Therapy Alone | 14 | |
| Overall Study | NOT COMPLETED | Speech Language Therapy and Acid Suppression Therapy | 11 |
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 | Emergency department visit broken femur | Musculoskeletal and connective tissue disorders | Speech Language Therapy Alone | 1 | 34 | 1 |
| other | Emergency department visit broken femur | Musculoskeletal and connective tissue disorders | Speech Language Therapy and Acid Suppression Therapy | 0 | 31 | 0 |
| other | Emergency department visit eczema and skin yeast infection | Skin and subcutaneous tissue disorders | Speech Language Therapy Alone | 1 | 34 | 1 |
| other | Emergency department visit eczema and skin yeast infection | Skin and subcutaneous tissue disorders | Speech Language Therapy and Acid Suppression Therapy | 0 | 31 | 0 |
| other | Emergency department visit viral syndrome | Infections and infestations | Speech Language Therapy Alone | 5 | 34 | 6 |
| other | Emergency department visit viral syndrome | Infections and infestations | Speech Language Therapy and Acid Suppression Therapy | 5 | 31 | 7 |
| other | Emergency department visit constipation | Gastrointestinal disorders | Speech Language Therapy Alone | 1 | 34 | 1 |
| other | Emergency department visit constipation | Gastrointestinal disorders | Speech Language Therapy and Acid Suppression Therapy | 0 | 31 | 0 |
| other | Emergency department post-fall | General disorders | Speech Language Therapy Alone | 0 | 34 | 0 |
| other | Emergency department post-fall | General disorders | Speech Language Therapy and Acid Suppression Therapy | 2 | 31 | 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 | Speech Language Therapy Alone | 0 | 34 |
| Total, all-cause mortality | Speech Language Therapy and Acid Suppression Therapy | 0 | 31 |
| Total, other adverse events | Speech Language Therapy Alone | 7 | 34 |
| Total, other adverse events | Speech Language Therapy and Acid Suppression Therapy | 8 | 31 |
| Total, serious adverse events | Speech Language Therapy Alone | 3 | 34 |
| Total, serious adverse events | Speech Language Therapy and Acid Suppression Therapy | 3 | 31 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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 |
| Speech Language Therapy Alone vs Speech Language Therapy and Acid Suppression Therapy: deaths from any cause | Trial comparisons |
Speech Language Therapy Alone vs Speech Language Therapy and Acid Suppression Therapy: Number of Participants With the Need for a Different Acid Suppression Therapy Medication (Other Than Famotidine) From the Day After the Consult up to the 3 Month Follow up Appointment | Trial comparisons |
| Speech Language Therapy Alone vs Speech Language Therapy and Acid Suppression Therapy: 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.
GET https://conductscience.org/api/trials/v1/NCT04614974
GET https://conductscience.org/api/trials/v1/NCT04614974/results?page=2