Acid Suppression Therapy for Laryngomalacia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding acid suppression therapy (AST) to speech language therapy improves symptoms in infants with laryngomalacia, a condition that causes noisy breathing. Researchers seek to assess whether AST, specifically using famotidine (a medication that reduces stomach acid), significantly enhances outcomes compared to speech therapy alone. The trial will clarify whether improvements in breathing and swallowing result from the treatment or occur naturally over time. Eligible infants are those under 6 months old with laryngomalacia, who do not have severe symptoms requiring surgery, and are seen at UPMC Children's Hospital of Pittsburgh. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial, smaller group of infants, contributing to important medical advancements.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that famotidine, a medicine used to reduce stomach acid, is usually safe for adults with heartburn and ulcers. However, its safety for infants remains less certain. Famotidine can cause side effects such as headaches, nausea, and stomach problems. While often used in adults, there is insufficient evidence to confirm its safety and effectiveness for infants with excess stomach acid. Therefore, caution is important when using it in young children and infants.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for laryngomalacia because they offer a unique combination that targets both swallowing mechanics and acid reflux, which are often interconnected issues in this condition. Typically, treatments for laryngomalacia might focus solely on surgical interventions or acid suppression alone. However, combining speech language therapy with acid suppression therapy, like famotidine, addresses the condition from two angles: improving swallowing function and reducing acid exposure. This dual approach could potentially lead to more comprehensive symptom relief and better quality of life for patients.
What evidence suggests that this trial's treatments could be effective for laryngomalacia?
Research suggests that medications like famotidine, which reduce stomach acid, might help with breathing issues in babies with laryngomalacia. Laryngomalacia is a condition where soft tissue above the vocal cords causes noisy breathing. One study found that both breathing and symptoms of acid reflux improved after using these medications. Another study showed that 62% of the babies experienced better swallowing and breathing. However, it's unclear if these improvements result from the medication or occur naturally as babies grow. In this trial, one group of participants will receive Speech Language Therapy alone, while another group will receive both Speech Language Therapy and Acid Suppression Therapy with famotidine. Since these medications can have side effects, especially in premature babies, careful consideration is necessary before using them.678910
Who Is on the Research Team?
Reema Padia, MD
Principal Investigator
Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Extended Follow-up
Participants are monitored for changes in airway and dysphagia symptoms, weight, and need for surgery up to 1 year.
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Reema Padia
Lead Sponsor
Citations
In Infants With Laryngomalacia, Does Acid-Blocking ...
The investigators hope to determine whether H2 blockers such as ranitidine and famotidine improve airway symptoms in babies with laryngomalacia. This will ...
Acid Suppression in Mild-Moderate Laryngomalacia Without ...
Results: Sixty-five patients enrolled; 40/65 (62%) followed up at a mean of 3.1 months (SD 1.4 months). Of these 40, 10 (25%) had mild and 30 ( ...
Acid Suppression in Mild‐Moderate Laryngomalacia ...
In the present randomized, controlled trial, both airway and GER symptoms improved at follow-up compared with the initial visit as measured ...
In Infants With Laryngomalacia, Does Acid-Blocking ...
In infants with symptoms of tracheomalacia or laryngomalacia, does acid-blocking medication improve respiratory symptoms?
Airway and Swallowing Outcomes in Children With ...
Laryngomalacia (LM) and laryngeal cleft (LC) can independently cause dysphagia but rarely can occur concomitantly.
Acid Suppression Does Not Improve Laryngomalacia ...
Acid suppression use does not reduce the frequency of supraglottoplasty and related hospitalizations compared to untreated subjects.
Famotidine: Uses, Interactions, Mechanism of Action
Famotidine is a histamine H2 receptor antagonist used to treat duodenal ulcers, benign gastric ulcers, GERD, and Zollinger-Ellison syndrome.
Material Safety Data Sheet
Known Clinical Effects: Adverse effects most commonly reported in clinical use include headache, nausea and gastrointestinal disturbances.
Famotidine (oral route) - Side effects & dosage
Safety and efficacy have not been established in children to treat conditions causing too much stomach acid and to prevent an ulcer from coming ...
PEPCID AC (famotidine) Label - accessdata.fda.gov
JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. Do not use if carton is ...
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