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

NCT02700087 | Withdrawn

• 1 other identifier: IRB-35551
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laryngomalacia; Acid Reflux; Stridor

Keywords

Laryngomalacia

Outcome Measures

Primary Outcomes (1)

• Time to normalization of airway symptoms score

  The primary outcome measure will be the time for the ASQ score to drop to normal on ranitidine or famotidine versus placebo.

  10 months

Secondary Outcomes (1)

• Weight gain

  10 month

Study Arms (2)

H2 blocker versus placebo

PLACEBO COMPARATOR

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.

Drug: ranitidine or famotidine; Drug: Placebo

Treatment arm

ACTIVE COMPARATOR

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.

Drug: ranitidine or famotidine

Interventions

ranitidine or famotidine DRUG

Patients with symptomatic laryngomalacia will receive ranitidine, famotidine, or placebo medications in order to see if these medications help their symptoms to resolve.

H2 blocker versus placebo; Treatment arm

Placebo DRUG

Patients with symptomatic laryngomalacia who meet inclusion criteria will be randomized to receive placebo, ranitidine or famotidine, in order to see if these medications help their symptoms to resolve.

H2 blocker versus placebo

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• Thompson DM. Abnormal sensorimotor integrative function of the larynx in congenital laryngomalacia: a new theory of etiology. Laryngoscope. 2007 Jun;117(6 Pt 2 Suppl 114):1-33. doi: 10.1097/MLG.0b013e31804a5750.

  PMID: 17513991 BACKGROUND

• Olney DR, Greinwald JH Jr, Smith RJ, Bauman NM. Laryngomalacia and its treatment. Laryngoscope. 1999 Nov;109(11):1770-5. doi: 10.1097/00005537-199911000-00009.

  PMID: 10569405 BACKGROUND

MeSH Terms

Conditions

Laryngomalacia; Gastroesophageal Reflux; Respiratory Sounds

Interventions

Ranitidine; Famotidine

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Douglas R Sidell, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Med Center Line, Otolaryngology- Head and Neck Surgery

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 7, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)