What side effects are associated with this type of intervention?

Famotidine, a histamine H2-receptor antagonist used in the treatment of Laryngomalacia, can cause side effects such as headache, dizziness, constipation, and diarrhea. More serious but less common side effects include confusion, agitation, and arrhythmias. Given the concerns about side effects, particularly in infants, the use of acid suppression therapy should be judicious. Other treatments for Laryngomalacia may include speech language therapy, which generally has fewer side effects but may not be as effective in reducing acid-related symptoms.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for the treatment of Laryngomalacia. However, acid suppression therapy, such as the use of histamine H2 receptor antagonists like Famotidine, is commonly employed to manage associated gastroesophageal reflux symptoms in Laryngomalacia. These treatments aim to reduce stomach acid production, which can help alleviate airway and dysphagia symptoms in affected infants.

What other types of research exist?

Promising novel alternatives to Famotidine for Laryngomalacia patients include proton pump inhibitors (PPIs) such as omeprazole and lansoprazole, which are effective in reducing stomach acid production. Additionally, baclofen, which has shown efficacy in reducing gastroesophageal reflux symptoms, is another potential alternative.

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Acid Suppression Therapy for Laryngomalacia

Phase 1 & 2

Waitlist Available

Led By Reema Padia, MD

Research Sponsored by Reema Padia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric patients ages 0 to 6 months who do need meet the criteria at the initial appointment for supraglottoplasty

Be younger than 18 years old

Must not have

Patients with a prior cardiac surgery

Children over the age of 6 months old will be excluded from participation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Famotidine may cause side effects like headache, constipation or diarrhea in some infants. However, it's generally well-tolerated and serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had heart surgery in the past.

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I am under 6 months old.

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My child has severe breathing issues due to a weak voice box, causing blue spells, pauses in breathing, and poor weight gain.

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My throat collapses when I sleep, causing breathing issues.

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I need surgery due to my symptoms.

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My baby was born before 37 weeks of pregnancy.

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I was prescribed AST before seeing an ear, nose, and throat doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Airway symptom score change from consult (baseline) to 3 month follow-up appointment

Change in incidence of airway symptoms from consult up to 1 year assessed via electronic medical chart review

Deglutition Disorders

+1 more

Secondary study objectives

Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment

Number of participants with each type of laryngomalacia (Types 1-3) found on the Flexible Laryngoscopy procedure at the consult

Pharmaceutical Preparations

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Speech Language Therapy AloneExperimental Treatment1 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 TherapyActive Control2 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Laryngomalacia is often associated with gastroesophageal reflux (GER), which can exacerbate symptoms. Acid suppression therapy (AST) is commonly used to manage GER in these patients. Famotidine, an H2 receptor antagonist, reduces stomach acid production by blocking histamine H2 receptors on gastric parietal cells. This reduction in acid can help alleviate GER symptoms, potentially improving airway and swallowing issues in Laryngomalacia patients. Understanding the mechanism of action is crucial as it highlights the importance of reducing acid production to manage associated symptoms effectively.

Effect of a somatostatin analogue (SMS 201-995) on antral gastrin cell hyperplasia and hypergastrinemia induced by a histamine H2-receptor antagonist.Action of mifentidine on the secretory response to sham feeding and pentagastrin and on serum gastrin in duodenal ulcer patients.MK-208, a novel histamine H2-receptor inhibitor with prolonged antisecretory effect.