Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia

Who is this study for? Patients with Laryngomalacia, Gastro Esophageal Reflux
Status: Terminated
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
UPMC Children's Hospital of Pittsburgh
Pittsburgh
Time Frame
Start Date: 2020-11-18
Completion Date: 2024-05-17
Participants
Target number of participants: 65
Treatments
Experimental: Speech Language Therapy Alone
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.
Active_comparator: Speech Language Therapy and Acid Suppression Therapy
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.
Sponsors
Leads: Reema Padia

This content was sourced from clinicaltrials.gov