Acid Suppression Therapy for Laryngomalacia

Overseen By Amber D. Shaffer, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Reema Padia

Must not be taking: Acid suppression therapy

Disqualifiers: Premature, Lung disease, Craniofacial, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

65 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if adding an acid-reducing medication to speech therapy helps infants with breathing and swallowing issues more than speech therapy alone. The study focuses on babies with laryngomalacia. The goal is to see if the combined treatment is more effective in improving their symptoms.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are already on acid suppression therapy, you cannot participate in the trial.

Is acid suppression therapy safe for children and adolescents?

Acid-suppressant treatments, like proton pump inhibitors, are often used in children and adolescents, but they can lead to side effects and should be prescribed carefully. Safety data suggests that while these treatments are generally safe, they should be used prudently, especially in young patients. ^{1 2 3 4 5}

How does speech language therapy differ from other treatments for laryngomalacia?

Speech language therapy for laryngomalacia is unique because it focuses on improving vocal function and communication skills, rather than directly addressing acid reflux or inflammation like acid suppression drugs. This therapy may involve exercises and techniques to strengthen the voice and improve breathing, offering a non-drug approach to managing symptoms. ^{6 7 8 9 10}

Research Team

Reema Padia, MD

Principal Investigator

Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh

Eligibility Criteria

This trial is for infants aged 0 to 6 months with laryngomalacia, a condition causing noisy breathing, who haven't had prolonged cyanosis or apnea and are not failing to thrive. They must be seen at UPMC Children's Hospital of Pittsburgh without needing immediate surgery, have no craniofacial abnormalities, additional airway issues, prior heart surgery, syndromes or lung disease.

Inclusion Criteria

Seen in University of Pittsburgh Medical Center (UPMC) Children's Hospital of Pittsburgh (CHP) Otolaryngology Department

My condition does not cause long pauses in breathing, turning blue, or poor growth.

My child is 0-6 months old and does not qualify for throat surgery.

Exclusion Criteria

You have other abnormalities in your airways that were found before or during your consultation.

I have had heart surgery in the past.

I am under 6 months old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Evaluation and Treatment

Participants receive a routine swallowing evaluation by a speech language pathologist and may receive acid suppression therapy (famotidine). Caregivers fill out the I-GERQ-R and PASS surveys.

1 day

1 visit (in-person)

Follow-up

Participants are re-evaluated at their follow-up appointment in 3 months. Caregivers fill out the I-GERQ-R and PASS surveys again to determine LM severity.

3 months

1 visit (in-person)

Extended Follow-up

Participants are monitored for changes in airway and dysphagia symptoms, weight, and need for surgery up to 1 year.

1 year

Treatment Details

Interventions

• Famotidine
• Speech Language Therapy

Trial Overview The study compares the outcomes in infants with laryngomalacia using two approaches: one group receives speech language therapy (SLP) alone while the other gets SLP plus acid suppression therapy with famotidine. The goal is to see if famotidine improves symptoms compared to natural disease resolution.

Participant Groups

Group I: Speech Language Therapy Alone Experimental Treatment 1 Intervention

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.

Group II: Speech Language Therapy and Acid Suppression Therapy Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Reema Padia

Lead Sponsor

Trials

1

Recruited

70+

References

1. United States pubmed.ncbi.nlm.nih.gov

Trends and Correlates of Early-Life Exposure to Acid-Suppressant Therapy in Israel (2005-2020). [2023]

2. England pubmed.ncbi.nlm.nih.gov

Utilization and safety of proton-pump inhibitors and histamine-2 receptor antagonists in children and adolescents: an observational cohort study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A Multifaceted Intervention to Reduce Pediatric Acid-Suppressant Prescriptions for Gastroesophageal Reflux: What Have We Learned? [2019]

4. England pubmed.ncbi.nlm.nih.gov

Intravenous and oral lansoprazole are equivalent in suppressing stimulated acid output in patient volunteers with erosive oesophagitis. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical utility of esomeprazole for treatment of gastroesophageal reflux disease in pediatric and adolescent patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Outcomes of acid suppressive therapy in patients with posterior laryngitis. [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

[Diagnosis and therapy of laryngitis gastrica]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Acid reflux treatment for hoarseness. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of acid suppression therapy in gastroesophageal reflux disease-related chronic laryngitis. [2021]