initiation of acid suppression therapy prospective outcomes for laryngomalacia

Conditions: Laryngomalacia; Gastro Esophageal Reflux

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).

purpose: to determine the outcome differences in patients 6 months and younger with laryngomalacia and dysphagia who are evaluated by speech language therapy (slp) alone versus those with both slp evaluation and acid suppression therapy (ast) (famotidine) hypothesis: there will be no differences in outcomes between those that had slp alone versus those that had both slp and ast. 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. however, there is no gold standard in treating mild and moderate lm patients and therefore this study will help establish guidelines for treatment. a medical chart review will be performed to assess airway and dysphagia symptom improvement from consult to the 3-month follow up appointment and then up to a year. the pittsburgh airway symptom score (pass) questionnaire and the infant gastroesophageal reflux questionnaire (i-gerq-r) will be given to families at the consult and at the 3-month follow up appointment for caregiver assessment. the physician will then perform the standard procedures at the clinic appointment. the flexible laryngoscopy findings sheet will be filled out in conjunction with the clinic procedures for objective data. the surveys will then be scored to determine true gerd (score \>=16) and severe laryngomalacia (lm) (red questions on the pass), which would further exclude these patients. there are 12 total questions on the i-gerq-r. on the pass, questions 1 \& 2 are in the green category and signifies mild lm, yellow signifies moderate lm, and red is severe lm. on the pass questionnaire, "yes" to either #1 or #2 and nothing else is mild lm, "yes" to at least one #3-5 and none of #6-10 is moderate lm, and "yes" to any of the #6-10" indicates severe lm. there are 10 total questions on the pass. mild and moderate lm patients will be block randomized the day before the appointment to receive speech language therapy alone or speech language therapy with famotidine (pepcid). both treatments are standard of care in these patients. speech language therapy (feeding therapy) is part of the normal clinic visit for lm patients. these patients will then be re-evaluated at their follow up appointment in 3 months (+/- 1 month). the families will take the pass and i-gerq-r surveys again to determine lm severity.

Eligibility criteria:
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.

Keywords: laryngomalacia symptom improvement famotidine speech language therapy