Speech Language Therapy for Laryngomalacia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Laryngomalacia+1 MoreSpeech Language Therapy - Other
Eligibility
No minimum age - 6
All Sexes
What conditions do you have?
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Study Summary

This trial is studying whether a medicine can improve symptoms in infants with a common breathing problem called laryngomalacia.

Eligible Conditions
  • Laryngomalacia
  • Acid Reflux

Treatment Effectiveness

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: 1 year

1 year
Change in incidence of airway symptoms from consult up to 1 year assessed via electronic medical chart review
Deglutition Disorders
Number of participants with the need for supraglottoplasty surgery (escalation of treatment) up to 1 year
Weight (kg) from consult up to 1 year
3 months
Airway symptom score change from consult (baseline) to 3 month follow-up appointment
Dysphagia symptom score change from consult (baseline) to 3 month follow-up appointment
Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment
Pharmaceutical Preparations
Number of participants with the need for acid suppression therapy medication (famotidine) from speech language therapy alone group from the day after the consult up to the 3 month follow up appointment
At initial consult
Number of participants with each type of laryngomalacia (Types 1-3) found on the Flexible Laryngoscopy procedure at the consult

Trial Safety

Side Effects for

Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
16%Headache
This histogram enumerates side effects from a completed 2011 Phase 4 trial (NCT01232127) in the Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI ARM group. Side effects include: Headache with 16%.

Trial Design

2 Treatment Groups

Speech Language Therapy and Acid Suppression Therapy
1 of 2
Speech Language Therapy Alone
1 of 2

Active Control

Experimental Treatment

160 Total Participants · 2 Treatment Groups

Primary Treatment: Speech Language Therapy · No Placebo Group · Phase 1 & 2

Speech Language Therapy Alone
Other
Experimental Group · 1 Intervention: Speech Language Therapy · Intervention Types: Other
Speech Language Therapy and Acid Suppression TherapyActiveComparator Group · 2 Interventions: Speech Language Therapy, Famotidine · Intervention Types: Other, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Reema PadiaLead Sponsor
Reema Padia, MD5.01 ReviewsPrincipal Investigator - Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
University of Pittsburgh

Eligibility Criteria

Age No minimum age - 6 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient is a 3-year-old female who was seen in the CHP Otolaryngology Department for evaluation of bilateral hearing loss
The child has laryngomalacia, but does not have prolonged cyanosis, apnea, or failure to thrive.
with laryngotracheoplasty will usually be scheduled for surgery within 2 to 6 weeks after the initial evaluation
References