Clinical Trials


Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia

Intervention Type: Drug, Other
Study Type: Interventional
Sponsors: Reema Padia
Participants: 160
Reema Padia
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).
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UPMC Children's Hospital of Pittsburgh - Recruiting
Pittsburgh, United States of America
Amber D. Shaffer, PhD
Jennifer L. McCoy, MA
Sex: All
Maximum Age: 6 months
Healthy Volunteers: No
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.

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