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

Not Recruiting

Trial ID: NCT02700087

Purpose

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.

Official Title

In Infants With Symptoms of Tracheomalacia or Laryngomalacia, Does Acid-Blocking Medication Improve Respiratory Symptoms? A Randomized, Controlled Trial

Stanford Investigator(s)

Douglas Sidell, MD
Douglas Sidell, MD

Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics

Kay W. Chang, MD
Kay W. Chang, MD

Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics

Eligibility

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)

Intervention(s):

drug: ranitidine or famotidine

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lorene Nelson, PhD
650-723-6854