In Infants With Laryngomalacia, Does Acid-Blocking Medication Improve Respiratory Symptoms?

Laryngomalacia, or a soft, floppy upper airway, is the most common cause of noisy breathing
in neonates. It is caused by a combination of factors including neuromuscular weakness,
cartilaginous inadequacy, and anatomic abnormalities in the voice box. The majority of
affected babies' symptoms resolve by one year without intervention, but around 5% of cases
require surgical intervention to treat failure to thrive or obstructive sleep apnea.

Many babies with laryngomalacia are treated empirically with H2 blockers such as ranitidine
or famotidine to prevent reflux of stomach acid from causing further inflammation in an
already compromised upper airway. However, to date no study has been performed to show a
definitive benefit of these medications.

The investigators hope to determine whether H2 blockers such as ranitidine and famotidine
improve airway symptoms in babies with laryngomalacia. This will have an effect on practice
guideline for one of the most common problems encountered in pediatric otolaryngology.

All neonates, ages 0 to 4 months, presenting to LPCH pediatric ENT clinic for airway
difficulties or stridor will be screened for inclusion. As is consistent with an acceptable
standard of medical care, these children will undergo a flexible nasal endoscopic exam to
make the diagnosis of laryngomalacia, as well as be weighed and a breastfeeding history
taken. If laryngomalacia is present, the study staff with then administer the Infant
Gastroesophageal Reflux Questionnaire (IGERQ) and an airway symptoms questionnaire (ASQ).

Those babies with an IGERQ score of less than sixteen (no more than mild reflux) and an ASQ
score greater than six will be eligible for randomization. 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.

A secondary outcome will be weight gain in percentile. If the patient's I-GERQ score goes
above 16 at any time in the study, the patient will be crossed over to the treatment arm and
started on medical treatment.

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)