Trial Outcomes & Findings for Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia (NCT NCT04614974)
NCT ID: NCT04614974
Last Updated: 2025-07-20
Results Overview
Score change from pre to post surveys on the Pittsburgh Airway Symptom Score (PASS) questionnaire. The PASS is on a scale from 0-10 with a higher score indicating a worse outcome. This outcome will be assessed at the consult and the 3 month follow-up appointment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
3 months
Results posted on
2025-07-20
Participant Flow
Only infant patients were considered enrolled.
Participant milestones
| Measure |
Speech Language Therapy Alone
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
|
Speech Language Therapy and Acid Suppression Therapy
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Famotidine: Famotidine will be prescribed based on patients' weight. Caregivers will purchase this medication and dosage will be given to families in easy-to-understand language.
Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
31
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
| Measure |
Speech Language Therapy Alone
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
|
Speech Language Therapy and Acid Suppression Therapy
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Famotidine: Famotidine will be prescribed based on patients' weight. Caregivers will purchase this medication and dosage will be given to families in easy-to-understand language.
Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
11
|
Baseline Characteristics
Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
Baseline characteristics by cohort
| Measure |
Speech Language Therapy Alone
n=34 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=31 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.3 Months
n=5 Participants
|
2.3 Months
n=7 Participants
|
2.3 Months
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Follow-up PASS was completed by 20/34 (59%) in the speech language therapy alone group and 20/31 (65%) of the speech language therapy and acid suppression therapy group.
Score change from pre to post surveys on the Pittsburgh Airway Symptom Score (PASS) questionnaire. The PASS is on a scale from 0-10 with a higher score indicating a worse outcome. This outcome will be assessed at the consult and the 3 month follow-up appointment.
Outcome measures
| Measure |
Speech Language Therapy Alone
n=20 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=20 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
Baseline
|
3 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
|
Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
Change from baseline to 3 months
|
-2 score on a scale
Interval -5.0 to 2.0
|
-1 score on a scale
Interval -4.0 to 1.0
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Follow-up I-GERQ-R was completed by 20/34 (59%) in the speech language therapy alone group and 20/31 (65%) of the speech language therapy and acid suppression therapy group. However, 1 participant in the speech language therapy alone group only completed questions 1-6 of the I-GERQ-R and therefore was not included in analysis of total I-GERQ-R scores.
Score change from pre to post survey on the I-GERQ-R. There are 12 questions on the surveys on a scale of 0-42. A higher score indicates a worse outcome. Those with a score of \>=16 on this survey at the initial consult are excluded from the study, indicating true gastroesophageal reflux disease (GERD). This outcome will be assessed at the consult and the 3 month follow-up appointment.
Outcome measures
| Measure |
Speech Language Therapy Alone
n=19 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=20 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
Baseline
|
12 score on scale
Interval 6.0 to 15.0
|
10 score on scale
Interval 5.0 to 15.0
|
|
Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment
Change from baseline to 3 months
|
-4 score on scale
Interval -12.0 to 11.0
|
-3 score on scale
Interval -11.0 to 9.0
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 15 participants in the speech language therapy alone group and 21 participants in the speech language therapy and acid suppression therapy group had a follow-up otolaryngology clinic visit within 1 year of initial consult.
Change in prevalence of airway symptoms from consult up to 1 year assessed via electronic medical chart review. Notes from the Department of Otolaryngology will be reviewed which include reported symptoms from caregivers and symptoms seen upon exam. Airway symptoms included periods of apnea, chest wall retractions, cyanosis, stridor, noisy breathing, and increased respiratory rate.
Outcome measures
| Measure |
Speech Language Therapy Alone
n=15 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=21 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Noisy Breathing · Symptom present at consult, absent at follow-up
|
2 Participants
|
10 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Increased respiratory rate · Symptom present at consult, absent at follow-up
|
0 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Apnea · Symptom absent at consult and follow-up
|
14 Participants
|
20 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Apnea · Symptom present at consult, absent at follow-up
|
0 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Apnea · Symptom absent at consult, present at follow-up
|
0 Participants
|
1 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Apnea · Symptom present at consult and follow-up
|
1 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Chest Wall Retractions · Symptom absent at consult and follow-up
|
12 Participants
|
19 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Chest Wall Retractions · Symptom present at consult, absent at follow-up
|
2 Participants
|
1 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Chest Wall Retractions · Symptom absent at consult, present at follow-up
|
0 Participants
|
1 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Chest Wall Retractions · Symptom present at consult and follow-up
|
1 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Cyanosis · Symptom absent at consult and follow-up
|
15 Participants
|
21 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Cyanosis · Symptom present at consult, absent at follow-up
|
0 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Cyanosis · Symptom absent at consult, present at follow-up
|
0 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Cyanosis · Symptom present at consult and follow-up
|
0 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Stridor · Symptom absent at consult and follow-up
|
1 Participants
|
4 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Stridor · Symptom present at consult, absent at follow-up
|
5 Participants
|
7 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Stridor · Symptom absent at consult, present at follow-up
|
1 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Stridor · Symptom present at consult and follow-up
|
8 Participants
|
10 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Noisy Breathing · Symptom absent at consult and follow-up
|
2 Participants
|
1 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Noisy Breathing · Symptom absent at consult, present at follow-up
|
0 Participants
|
1 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Noisy Breathing · Symptom present at consult and follow-up
|
11 Participants
|
9 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Increased respiratory rate · Symptom absent at consult and follow-up
|
15 Participants
|
21 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Increased respiratory rate · Symptom absent at consult, present at follow-up
|
0 Participants
|
0 Participants
|
|
Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review
Increased respiratory rate · Symptom present at consult and follow-up
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 15 participants in the speech language therapy alone group and 21 participants in the speech language therapy and acid suppression therapy group had a follow-up otolaryngology clinic visit within 1 year of initial consult.
Change in prevalence of dysphagia symptoms from consult up to 1 year assessed via electronic medical chart review. Notes from the Department of Otolaryngology will be reviewed which include reported symptoms from caregivers and symptoms seen upon exam. Dysphagia symptoms included choking, coughing, gagging with feeds and/or emesis after feeds.
Outcome measures
| Measure |
Speech Language Therapy Alone
n=15 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=21 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Emesis · Symptom absent at consult and follow-up
|
3 Participants
|
7 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Emesis · Symptom present at consult, absent at follow-up
|
5 Participants
|
7 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Emesis · Symptom absent at consult, present at follow-up
|
2 Participants
|
1 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Emesis · Symptom present at consult and follow-up
|
5 Participants
|
6 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Choking · Symptom absent at consult and follow-up
|
9 Participants
|
11 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Choking · Symptom present at consult, absent at follow-up
|
5 Participants
|
3 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Choking · Symptom absent at consult, present at follow-up
|
0 Participants
|
3 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Choking · Symptom present at consult and follow-up
|
1 Participants
|
4 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Coughing · Symptom absent at consult and follow-up
|
7 Participants
|
9 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Coughing · Symptom present at consult, absent at follow-up
|
7 Participants
|
5 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Coughing · Symptom absent at consult, present at follow-up
|
0 Participants
|
5 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Coughing · Symptom present at consult and follow-up
|
1 Participants
|
2 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Gagging · Symptom absent at consult and follow-up
|
13 Participants
|
17 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Gagging · Symptom present at consult, absent at follow-up
|
2 Participants
|
2 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Gagging · Symptom absent at consult, present at follow-up
|
0 Participants
|
2 Participants
|
|
Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart
Gagging · Symptom present at consult and follow-up
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 20 patients in the speech language therapy alone group and 27 patients in the speech therapy and acid suppression therapy group had weights available in the electronic medical record from at least 1 follow-up appointment with any specialty within 1 year.
Weight change in kilograms per month assessed from medical chart review from consult up to 1 year
Outcome measures
| Measure |
Speech Language Therapy Alone
n=20 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=27 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
Weight (kg/Month) From Consult up to 1 Year
|
0.62 kg/month
Interval 0.27 to 1.04
|
0.56 kg/month
Interval 0.24 to 0.84
|
SECONDARY outcome
Timeframe: 1 yearThe need for escalation of treatment with supraglottoplasty surgery will be assessed through medical chart review up to 1 year.
Outcome measures
| Measure |
Speech Language Therapy Alone
n=34 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=31 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe speech language therapy alone group will be assessed for the need for a prescription for acid suppression therapy (famotidine) from the day after the consult up to 1 year.
Outcome measures
| Measure |
Speech Language Therapy Alone
n=34 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
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 1 Year
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: At initial consultAll patients will be scoped with a flexible laryngoscopy at the initial consult and the type of laryngomalacia (Types 1-3) will be noted. Participants are reported for each type of laryngomalacia noted at the initial consent. Participants can have more than one type of laryngomalacia. Type 1 is characterized by anterior/medial collapse of supra-arytenoid mucosa. Type 2 is characterized by short aryepiglottic folds. Type 3 is characterized by posterior collapse of epiglottis. None are considered better/worse outcomes.
Outcome measures
| Measure |
Speech Language Therapy Alone
n=34 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=31 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the Consult
Type 1-Anterior/medial collapse of supra-arytenoid mucosa
|
29 Participants
|
27 Participants
|
|
Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the Consult
Type 2-Short AE folds
|
24 Participants
|
19 Participants
|
|
Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the Consult
Type 3- Posterior collapse of epiglottis
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 monthsBoth groups will be assessed for the need for a different acid suppression therapy medication (other than famotidine) from the day after the consult up to the 3 month follow up appointment.
Outcome measures
| Measure |
Speech Language Therapy Alone
n=34 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
Speech Language Therapy and Acid Suppression Therapy
n=31 Participants
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
|
|---|---|---|
|
Number of Participants With the Need for a Different Acid Suppression Therapy Medication (Other Than Famotidine) From the Day After the Consult up to the 3 Month Follow up Appointment
|
0 Participants
|
2 Participants
|
Adverse Events
Speech Language Therapy Alone
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Speech Language Therapy and Acid Suppression Therapy
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Speech Language Therapy Alone
n=34 participants at risk
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
|
Speech Language Therapy and Acid Suppression Therapy
n=31 participants at risk
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Famotidine: Famotidine will be prescribed based on patients' weight. Caregivers will purchase this medication and dosage will be given to families in easy-to-understand language.
Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
|
|---|---|---|
|
Infections and infestations
Hospital admission for viral infection
|
5.9%
2/34 • Number of events 4 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Pediatric intensive care unit admission for respiratory distress following supraglottoplasty
|
2.9%
1/34 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
|
Reproductive system and breast disorders
Inguinal hernia with incarceration requiring surgery
|
0.00%
0/34 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hospital admission for seizure
|
0.00%
0/34 • 1 year
|
6.5%
2/31 • Number of events 2 • 1 year
|
|
General disorders
Hospital admission for monitoring post-motor vehicle accident
|
0.00%
0/34 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Speech Language Therapy Alone
n=34 participants at risk
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
|
Speech Language Therapy and Acid Suppression Therapy
n=31 participants at risk
Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Famotidine: Famotidine will be prescribed based on patients' weight. Caregivers will purchase this medication and dosage will be given to families in easy-to-understand language.
Speech Language Therapy: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Emergency department visit broken femur
|
2.9%
1/34 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
|
Skin and subcutaneous tissue disorders
Emergency department visit eczema and skin yeast infection
|
2.9%
1/34 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
|
Infections and infestations
Emergency department visit viral syndrome
|
14.7%
5/34 • Number of events 6 • 1 year
|
16.1%
5/31 • Number of events 7 • 1 year
|
|
Gastrointestinal disorders
Emergency department visit constipation
|
2.9%
1/34 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
|
General disorders
Emergency department post-fall
|
0.00%
0/34 • 1 year
|
6.5%
2/31 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Emergency department visit abscess
|
0.00%
0/34 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Emergency department visit tachypnea, fussiness, spitting up
|
0.00%
0/34 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
|
Nervous system disorders
Emergency department visit seizures
|
0.00%
0/34 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
Additional Information
Dr. Amber Shaffer
UPMC Children's Hospital of Pittsburgh
Phone: 412-692-6874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place