Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia (NCT04614974) | Clinical Trial Compass
TerminatedPhase 1/2
Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
Stopped: Slow recruitment due to few eligible patients
United States65 participantsStarted 2020-11-18
Plain-language 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. 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).
Who can participate
Age range
0 Months – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
Timeframe: 3 months
2
Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
Timeframe: 3 months
3
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Timeframe: 1 year
4
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart