LaryngomalaciaPhase 1/2NCT04614974
Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
A Phase 1/2 study testing Famotidine and Speech Language Therapy in people with Laryngomalacia and Gastro Esophageal Reflux, run by Reema Padia at 1 site in United States.
Trial summary
Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Laryngomalacia, Gastro Esophageal Reflux
- What is being tested?
- Famotidine and Speech Language Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 17 May 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients ages 0 to 6 months who do need meet the criteria at the initial appointment for supraglottoplasty
- Seen in University of Pittsburgh Medical Center (UPMC) Children's Hospital of Pittsburgh (CHP) Otolaryngology Department
- Laryngomalacia without prolonged (>20 seconds) cyanosis, apnea, nor failure to thrive.
Who cannot join
- Children over the age of 6 months old will be excluded from participation.
- Premature infants (<37 weeks gestation)
- Patients with lung disease.
- Laryngomalacia with prolonged (>20 seconds) cyanosis, apnea, and failure to thrive
- Sleep induced laryngomalacia
- Patients with craniofacial abnormalities
Show all 11Show fewer
- Patients with a syndrome
- Patients with additional airway abnormalities, seen before or at consult
- Patients with symptoms that necessitate surgery
- Patients with a prior cardiac surgery
- Patients with AST prescribed prior to the initial otolaryngology consult.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. The investigators recently performed a retrospective chart review assessing improvement of airway and dysphagia symptoms, weight gain, and need for surgery with AST. It was found that there was a similar improvement between LM severity groups and most patients received AST (96.6%). It is unclear if these improvements are due to AST or natural resolution of the disease. With heightened concerns of side effects related to AST in infants, particularly among those born prematurely, judicious use of these medications is needed. The investigators are now performing a prospective study looking at the outcome differences in patients with laryngomalacia who are evaluated by speech language therapy (SLP) alone versus those with SLP evaluation and acid suppression therapy (famotidine).
Read the detailed description
Purpose: To determine the outcome differences in patients 6 months and younger with laryngomalacia and dysphagia who are evaluated by speech language therapy (SLP) alone versus those with both SLP evaluation and acid suppression therapy (AST) (famotidine)
Hypothesis: There will be no differences in outcomes between those that had SLP alone versus those that had both SLP and AST.
Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. However, there is no gold standard in treating mild and moderate LM patients and therefore this study will help establish guidelines for treatment.
A medical chart review will be performed to assess airway and dysphagia symptom improvement from consult to the 3-month follow up appointment and then up to a year. The Pittsburgh Airway Symptom Score (PASS) questionnaire and the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) will be given to families at the consult and at the 3-month follow up appointment for caregiver assessment. The physician will then perform the standard procedures at the clinic appointment. The Flexible Laryngoscopy Findings sheet will be filled out in conjunction with the clinic procedures for objective data. The surveys will then be scored to determine true GERD (score >=16) and severe laryngomalacia (LM) (RED questions on the PASS), which would further exclude these patients. There are 12 total questions on the I-GERQ-R. On the PASS, questions 1 \& 2 are in the GREEN category and signifies mild LM, YELLOW signifies moderate LM, and RED is severe LM. On the PASS questionnaire, "Yes" to either #1 or #2 and nothing else is mild LM, "yes" to at least one #3-5 and none of #6-10 is moderate LM, and "yes" to any of the #6-10" indicates severe LM. There are 10 total questions on the PASS. Mild and moderate LM patients will be block randomized the day before the appointment to receive speech language therapy alone or speech language therapy with famotidine (Pepcid). Both treatments are standard of care in these patients. Speech language therapy (feeding therapy) is part of the normal clinic visit for LM patients. These patients will then be re-evaluated at their follow up appointment in 3 months (+/- 1 month). The families will take the PASS and I-GERQ-R surveys again to determine LM severity.
Initially, primary outcome #2 was "Dysphagia symptom score change from consult (baseline) to 3 month follow-up appointment." This is the same as the original secondary outcome measure #6 "Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment" (I-GERQ-R is the dysphagia symptom score used in this study). Therefore, these were consolidated to a single primary outcome measure "Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment." This change was made after study and data collection completion, at the time of results reporting.
- Conditions
- Laryngomalacia, Gastro Esophageal Reflux
- Being tested
- Famotidine, Speech Language Therapy
- Keywords
- Laryngomalacia, Symptom improvement, Famotidine, Speech Language Therapy
- Medical subject headings
- Laryngomalacia, Gastroesophageal Reflux, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamotidineDrug
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 TherapyOther
Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
| Study group | Role | What they receive |
|---|---|---|
| Speech Language Therapy Alone | Experimental | 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. Receives: Other: Speech Language Therapy |
| Speech Language Therapy and Acid Suppression Therapy | Active comparator | 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. Receives: Drug: Famotidine; Other: Speech Language Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
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.
Measured: 3 months
Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
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.
Measured: 3 months
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
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.
Measured: 1 year
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
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.
Measured: 1 year
Secondary outcomes (5)
Weight (kg/Month) From Consult up to 1 Year
Weight change in kilograms per month assessed from medical chart review from consult up to 1 year
Measured: 1 year
Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year
The need for escalation of treatment with supraglottoplasty surgery will be assessed through medical chart review up to 1 year.
Measured: 1 year
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
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.
Measured: 1 year
Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the 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.
Measured: At initial consult
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
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start18 Nov 2020
- Primary completion17 May 2024
- Study completion17 May 2024
Why it stopped: Slow recruitment due to few eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LaryngomalaciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, open-label randomized control trial
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reema Padia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reema Padia, University of Pittsburgh
- Investigators
- Reema Padia, MD, Principal investigator, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614974
- Sponsor's protocol ID
- STUDY20090193
- Status last verified
- Jul 2025
- First submitted
- 22 Oct 2020
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosbe KW, Kenna MA, Auerbach AD. Extraesophageal reflux in pediatric patients with upper respiratory symptoms. Arch Otolaryngol Head Neck Surg. 2003 Nov;129(11):1213-20. doi: 10.1001/archotol.129.11.1213.
PubMed 14623753Hartl TT, Chadha NK. A systematic review of laryngomalacia and acid reflux. Otolaryngol Head Neck Surg. 2012 Oct;147(4):619-26. doi: 10.1177/0194599812452833. Epub 2012 Jun 27.
PubMed 22745201Bibi H, Khvolis E, Shoseyov D, Ohaly M, Ben Dor D, London D, Ater D. The prevalence of gastroesophageal reflux in children with tracheomalacia and laryngomalacia. Chest. 2001 Feb;119(2):409-13. doi: 10.1378/chest.119.2.409.
PubMed 11171716Landry AM, Thompson DM. Laryngomalacia: disease presentation, spectrum, and management. Int J Pediatr. 2012;2012:753526. doi: 10.1155/2012/753526. Epub 2012 Feb 27.
PubMed 22518182Thompson DM. Laryngomalacia: factors that influence disease severity and outcomes of management. Curr Opin Otolaryngol Head Neck Surg. 2010 Dec;18(6):564-70. doi: 10.1097/MOO.0b013e3283405e48.
PubMed 20962644Shaffer AD, Balogun Z, Tobey ABJ, Maguire RC, Simons JP, Dohar JE, Mccoy JL, Rushchak MV, Padia R. Acid Suppression in Mild-Moderate Laryngomalacia Without GERD: A Randomized Controlled Trial. Laryngoscope. 2026 Jan;136(1):471-478. doi: 10.1002/lary.32471. Epub 2025 Aug 5.
PubMed 40762274
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
- ClinicalTrials.gov ID
- NCT04614974
- Acronym / sponsor ID
- STUDY20090193
- Conditions
- Laryngomalacia, Gastro Esophageal Reflux
- Keywords
- Laryngomalacia, Symptom improvement, Famotidine, Speech Language Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment due to few eligible patients
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Reema PadiaUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Posted 20 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. The investigators recently performed a retrospective chart review assessing improvement of airway and dysphagia symptoms, weight gain, and need for surgery with AST. It was found that there was a similar improvement between LM severity groups and most patients received AST (96.6%). It is unclear if these improvements are due to AST or natural resolution of the disease. With heightened concerns of side effects related to AST in infants, particularly among those born prematurely, judicious use of these medications is needed. The investigators are now performing a prospective study looking at the outcome differences in patients with laryngomalacia who are evaluated by speech language therapy (SLP) alone versus those with SLP evaluation and acid suppression therapy (famotidine).
Detailed description
Purpose: To determine the outcome differences in patients 6 months and younger with laryngomalacia and dysphagia who are evaluated by speech language therapy (SLP) alone versus those with both SLP evaluation and acid suppression therapy (AST) (famotidine)
Hypothesis: There will be no differences in outcomes between those that had SLP alone versus those that had both SLP and AST.
Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. However, there is no gold standard in treating mild and moderate LM patients and therefore this study will help establish guidelines for treatment.
A medical chart review will be performed to assess airway and dysphagia symptom improvement from consult to the 3-month follow up appointment and then up to a year. The Pittsburgh Airway Symptom Score (PASS) questionnaire and the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) will be given to families at the consult and at the 3-month follow up appointment for caregiver assessment. The physician will then perform the standard procedures at the clinic appointment. The Flexible Laryngoscopy Findings sheet will be filled out in conjunction with the clinic procedures for objective data. The surveys will then be scored to determine true GERD (score >=16) and severe laryngomalacia (LM) (RED questions on the PASS), which would further exclude these patients. There are 12 total questions on the I-GERQ-R. On the PASS, questions 1 \& 2 are in the GREEN category and signifies mild LM, YELLOW signifies moderate LM, and RED is severe LM. On the PASS questionnaire, "Yes" to either #1 or #2 and nothing else is mild LM, "yes" to at least one #3-5 and none of #6-10 is moderate LM, and "yes" to any of the #6-10" indicates severe LM. There are 10 total questions on the PASS. Mild and moderate LM patients will be block randomized the day before the appointment to receive speech language therapy alone or speech language therapy with famotidine (Pepcid). Both treatments are standard of care in these patients. Speech language therapy (feeding therapy) is part of the normal clinic visit for LM patients. These patients will then be re-evaluated at their follow up appointment in 3 months (+/- 1 month). The families will take the PASS and I-GERQ-R surveys again to determine LM severity.
Initially, primary outcome #2 was "Dysphagia symptom score change from consult (baseline) to 3 month follow-up appointment." This is the same as the original secondary outcome measure #6 "Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment" (I-GERQ-R is the dysphagia symptom score used in this study). Therefore, these were consolidated to a single primary outcome measure "Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment." This change was made after study and data collection completion, at the time of results reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental, open-label randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Speech Language Therapy Alone | Experimental | Other: Speech Language TherapyPatients 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 and Acid Suppression Therapy | Active comparator | Drug: Famotidine, Other: Speech Language TherapyPatients 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. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients ages 0 to 6 months who do need meet the criteria at the initial appointment for supraglottoplasty
- Seen in University of Pittsburgh Medical Center (UPMC) Children's Hospital of Pittsburgh (CHP) Otolaryngology Department
- Laryngomalacia without prolonged (>20 seconds) cyanosis, apnea, nor failure to thrive.
Key exclusion criteria (11 listed)
- Children over the age of 6 months old will be excluded from participation.
- Premature infants (<37 weeks gestation)
- Patients with lung disease.
- Laryngomalacia with prolonged (>20 seconds) cyanosis, apnea, and failure to thrive
- Sleep induced laryngomalacia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamotidineFamotidine will be prescribed based on patients' weight. Caregivers will purchase this medication and dosage will be given to families in easy-to-understand language. | Drug | Speech Language Therapy and Acid Suppression Therapy |
| Speech Language TherapySpeech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing. | Other | Speech Language Therapy Alone, Speech Language Therapy and Acid Suppression Therapy |
Primary outcome
Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
Time frame: 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.
Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
Time frame: 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.
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Time frame: 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.
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Time frame: 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.
5 secondary outcomes
Weight (kg/Month) From Consult up to 1 Year
Time frame: 1 year
Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year
Time frame: 1 year
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
Time frame: 1 year
Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the Consult
Time frame: At initial consult
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
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14623753Rosbe KW, Kenna MA, Auerbach AD. Extraesophageal reflux in pediatric patients with upper respiratory symptoms. Arch Otolaryngol Head Neck Surg. 2003 Nov;129(11):1213-20. doi: 10.1001/archotol.129.11.1213.
- Background: PubMed 22745201Hartl TT, Chadha NK. A systematic review of laryngomalacia and acid reflux. Otolaryngol Head Neck Surg. 2012 Oct;147(4):619-26. doi: 10.1177/0194599812452833. Epub 2012 Jun 27.
- Background: PubMed 11171716Bibi H, Khvolis E, Shoseyov D, Ohaly M, Ben Dor D, London D, Ater D. The prevalence of gastroesophageal reflux in children with tracheomalacia and laryngomalacia. Chest. 2001 Feb;119(2):409-13. doi: 10.1378/chest.119.2.409.
- Background: PubMed 22518182Landry AM, Thompson DM. Laryngomalacia: disease presentation, spectrum, and management. Int J Pediatr. 2012;2012:753526. doi: 10.1155/2012/753526. Epub 2012 Feb 27.
- Background: PubMed 20962644Thompson DM. Laryngomalacia: factors that influence disease severity and outcomes of management. Curr Opin Otolaryngol Head Neck Surg. 2010 Dec;18(6):564-70. doi: 10.1097/MOO.0b013e3283405e48.
- Derived from this study: PubMed 40762274Shaffer AD, Balogun Z, Tobey ABJ, Maguire RC, Simons JP, Dohar JE, Mccoy JL, Rushchak MV, Padia R. Acid Suppression in Mild-Moderate Laryngomalacia Without GERD: A Randomized Controlled Trial. Laryngoscope. 2026 Jan;136(1):471-478. doi: 10.1002/lary.32471. Epub 2025 Aug 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reema Padia, MD principal investigator
Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Famotidine and Speech Language Therapy in people with Laryngomalacia and Gastro Esophageal Reflux, run by Reema Padia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614974, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.