In Infants With Laryngomalacia, Does Acid-Blocking Medication Improve Respiratory Symptoms?
Laryngomalacia, Acid Reflux, Stridor
About this trial
This is an interventional treatment trial for Laryngomalacia focused on measuring Laryngomalacia
Eligibility Criteria
Inclusion Criteria:
- age 0 - 4 months old
- stridor and flexible laryngoscopy demonstrating laryngomalacia
- airway symptom score over 4
- only has physiologic GER (I-GERQ < 16)
Exclusion Criteria:
- requiring surgery for LGM
- other airway dz seen on flexible laryngoscopy
- history of or already on PPI therapy
- minimal/mild airway symptoms (airway score < 4)
- pathologic GERD (I-GERQ greater than 16) - These pts cannot be randomized because this is the standard score in Pediatric GI literature strongly indicating anti-reflux meds
- premature birth (< 36 weeks)
Sites / Locations
- Lucile Packard Children's Hospital Stanford
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
H2 blocker versus placebo
Treatment arm
The patient will then be randomly placed in the control group (placebo) or the intervention group (ranitidine 2mg/kg every 12 hours or famotidine 0.5 mg/kg daily). Patients will stay on medication for a minimum of 6 months, or until symptoms resolve. Patients will be seen in follow up at 1, 2, 3, 4, 5, 6, 8 and 10 months. At which time I-GERQ, ASQ and weights will be taken. The primary outcome measure will be the time for the ASQ score to drop to normal on ranitidine or famotidine versus placebo.
Patients who develop severe airway symptoms while they are in the H2 blocker versus placebo arm will then cross over to the treatment arm of the study. These patients will exit randomization and be unblinded. These patients will all be given H2 blockers, and the effects of the H2 blockers will be monitored and studied. Alternatively, patients' families may also elect to undergo surgery to treat laryngomalacia.