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Acid Suppression Therapy for Laryngomalacia
Study Summary
This trial is studying whether a medicine can improve symptoms in infants with a common breathing problem called laryngomalacia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 4 trial • 25 Patients • NCT01232127Trial Design
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Who is running the clinical trial?
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- You have other abnormalities in your airways that were found before or during your consultation.I have had heart surgery in the past.I am under 6 months old.My child has severe breathing issues due to a weak voice box, causing blue spells, pauses in breathing, and poor weight gain.My condition does not cause long pauses in breathing, turning blue, or poor growth.My throat collapses when I sleep, causing breathing issues.I need surgery due to my symptoms.I have a lung condition.I need more information to accurately summarize this criterion. "Patients with a syndrome" is too broad and could refer to many different conditions. If you can provide more details, I can help you summarize this criterion more effectively.My baby was born before 37 weeks of pregnancy.You have abnormalities in the shape of your head or face.My child is 0-6 months old and does not qualify for throat surgery.I was prescribed AST before seeing an ear, nose, and throat doctor.
- Group 1: Speech Language Therapy Alone
- Group 2: Speech Language Therapy and Acid Suppression Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What criteria must I fulfill in order to be eligible for this experiment?
"This medical trial is requiring 160 infant patients with gastroesophageal reflux between 0 and 6 months of age. To qualify, they must have been seen at UPMC Children's Hospital of Pittsburgh Otolaryngology Department for laryngomalacia without any prolonged episodes (>20 seconds) of cyanosis, apnea or failure to thrive. Additionally, infants who don't meet the criteria upon their initial appointment for supraglottoplasty are ineligible as well."
What outcomes is this clinical investigation striving to accomplish?
"This one-year evaluation attempts to measure the alteration in airway symptoms via electronic medical chart review. Secondary outcomes include alterations of weight, Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) scores at both initial consult and 3 month follow up appointment, and participants who need supraglottoplasty surgery within a year. Participants with I-GERQ-R score >=16 will be excluded due to existing GERD diagnosis."
Has other research been conducted into Speech Language Therapy's efficacy?
"Currently, 14 research projects focused on Speech Language Therapy are underway with 3 reaching the final Phase of testing. Of the 64 clinical trial sites used for this purpose, most are located in Pittsburgh, Pennsylvania."
To what types of afflictions is Speech Language Therapy commonly employed?
"Speech Language Therapy is a common intervention for gastritis and also beneficial in treating other illnesses, such as heartburn, zollinger-ellison syndrome, or collagen diseases."
Does this study welcome elderly participants who are 75 years and older?
"According to the requirements of this investigation, participants must be within the 0 Month - 6 Month age bracket. This trial is targeting 17 children under 18 and 64 seniors over 65 years old."
What is the upper limit of participants in this clinical investigation?
"Affirmative. By consulting clinicaltrials.gov, it is possible to determine that this study commenced on November 18th 2020 and requires 160 participants from 1 site for its completion."
Is this research endeavor presently accepting new participants?
"As per the information on clinicaltrials.gov, this trial is presently recruiting eligible participants. It was initially announced on November 18th 2020 and most recently updated on November 8th 2022."
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