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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Laryngomalacia, Acid Reflux, Stridor

In brief

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.

Key facts

Study ID

NCT02700087

Run by

Stanford University

People needed

0

Starts

2016-02-01

Expected to finish

2017-02-01

Last updated by the study team

2017-11-17

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 0 - 4 months old
• stridor and flexible laryngoscopy demonstrating laryngomalacia
• airway symptom score over 4
• only has physiologic GER (I-GERQ < 16)

You may not qualify if…

• 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)

Where it is running

• Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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