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Slow recruitment due to few eligible patients
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Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. The investigators recently performed a retrospective chart review assessing improvement of airway and dysphagia symptoms, weight gain, and need for surgery with AST. It was found that there was a similar improvement between LM severity groups and most patients received AST (96.6%). It is unclear if these improvements are due to AST or natural resolution of the disease. With heightened concerns of side effects related to AST in infants, particularly among those born prematurely, judicious use of these medications is needed. The investigators are now performing a prospective study looking at the outcome differences in patients with laryngomalacia who are evaluated by speech language therapy (SLP) alone versus those with SLP evaluation and acid suppression therapy (famotidine).
Purpose: To determine the outcome differences in patients 6 months and younger with laryngomalacia and dysphagia who are evaluated by speech language therapy (SLP) alone versus those with both SLP evaluation and acid suppression therapy (AST) (famotidine)
Hypothesis: There will be no differences in outcomes between those that had SLP alone versus those that had both SLP and AST.
Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. However, there is no gold standard in treating mild and moderate LM patients and therefore this study will help establish guidelines for treatment.
A medical chart review will be performed to assess airway and dysphagia symptom improvement from consult to the 3-month follow up appointment and then up to a year. The Pittsburgh Airway Symptom Score (PASS) questionnaire and the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) will be given to families at the consult and at the 3-month follow up appointment for caregiver assessment. The physician will then perform the standard procedures at the clinic appointment. The Flexible Laryngoscopy Findings sheet will be filled out in conjunction with the clinic procedures for objective data. The surveys will then be scored to determine true GERD (score >=16) and severe laryngomalacia (LM) (RED questions on the PASS), which would further exclude these patients. There are 12 total questions on the I-GERQ-R. On the PASS, questions 1 & 2 are in the GREEN category and signifies mild LM, YELLOW signifies moderate LM, and RED is severe LM. On the PASS questionnaire, "Yes" to either #1 or #2 and nothing else is mild LM, "yes" to at least one #3-5 and none of #6-10 is moderate LM, and "yes" to any of the #6-10" indicates severe LM. There are 10 total questions on the PASS. Mild and moderate LM patients will be block randomized the day before the appointment to receive speech language therapy alone or speech language therapy with famotidine (Pepcid). Both treatments are standard of care in these patients. Speech language therapy (feeding therapy) is part of the normal clinic visit for LM patients. These patients will then be re-evaluated at their follow up appointment in 3 months (+/- 1 month). The families will take the PASS and I-GERQ-R surveys again to determine LM severity.
Initially, primary outcome #2 was "Dysphagia symptom score change from consult (baseline) to 3 month follow-up appointment." This is the same as the original secondary outcome measure #6 "Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment" (I-GERQ-R is the dysphagia symptom score used in this study). Therefore, these were consolidated to a single primary outcome measure "Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment." This change was made after study and data collection completion, at the time of results reporting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Speech Language Therapy Alone | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famotidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | 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. | 3 months |
| Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | 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. | 3 months |
| Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review | 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. | 1 year |
| Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (kg/Month) From Consult up to 1 Year | Weight change in kilograms per month assessed from medical chart review from consult up to 1 year | 1 year |
| Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reema Padia, MD | Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14623753 | Background | Rosbe KW, Kenna MA, Auerbach AD. Extraesophageal reflux in pediatric patients with upper respiratory symptoms. Arch Otolaryngol Head Neck Surg. 2003 Nov;129(11):1213-20. doi: 10.1001/archotol.129.11.1213. | |
| 22745201 | Background | Hartl TT, Chadha NK. A systematic review of laryngomalacia and acid reflux. Otolaryngol Head Neck Surg. 2012 Oct;147(4):619-26. doi: 10.1177/0194599812452833. Epub 2012 Jun 27. |
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Only infant patients were considered enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at initial consult |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | 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. | 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. | Posted | Median | Full Range | score on a scale | 3 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission for viral infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency department visit broken femur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amber Shaffer | UPMC Children's Hospital of Pittsburgh | 412-692-6874 | shafferad@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2021 | May 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2022 | May 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055092 | Laryngomalacia |
| D005764 | Gastroesophageal Reflux |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D002357 | Cartilage Diseases |
| D009140 | Musculoskeletal Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015738 | Famotidine |
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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Experimental, open-label randomized control trial
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Open Label
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| Speech Language Therapy | Other | Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing. |
|
The need for escalation of treatment with supraglottoplasty surgery will be assessed through medical chart review up to 1 year. |
| 1 year |
| 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 | The 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. | 1 year |
| Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the Consult | All 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. | At initial consult |
| 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 | Both 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. | 3 months |
| 11171716 | Background | Bibi H, Khvolis E, Shoseyov D, Ohaly M, Ben Dor D, London D, Ater D. The prevalence of gastroesophageal reflux in children with tracheomalacia and laryngomalacia. Chest. 2001 Feb;119(2):409-13. doi: 10.1378/chest.119.2.409. |
| 22518182 | Background | Landry AM, Thompson DM. Laryngomalacia: disease presentation, spectrum, and management. Int J Pediatr. 2012;2012:753526. doi: 10.1155/2012/753526. Epub 2012 Feb 27. |
| 20962644 | Background | Thompson DM. Laryngomalacia: factors that influence disease severity and outcomes of management. Curr Opin Otolaryngol Head Neck Surg. 2010 Dec;18(6):564-70. doi: 10.1097/MOO.0b013e3283405e48. |
| 40762274 | Derived | Shaffer AD, Balogun Z, Tobey ABJ, Maguire RC, Simons JP, Dohar JE, Mccoy JL, Rushchak MV, Padia R. Acid Suppression in Mild-Moderate Laryngomalacia Without GERD: A Randomized Controlled Trial. Laryngoscope. 2026 Jan;136(1):471-478. doi: 10.1002/lary.32471. Epub 2025 Aug 5. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Full Range |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Primary | Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult (Baseline) to 3 Month Follow-up Appointment | 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. | 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. | Posted | Median | Full Range | score on scale | 3 months |
|
|
|
|
| Primary | Change in Prevalence of Airway Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart Review | 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. | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| Primary | Change in Prevalence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via Electronic Medical Chart | 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. | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| Secondary | Weight (kg/Month) From Consult up to 1 Year | Weight change in kilograms per month assessed from medical chart review from consult up to 1 year | 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. | Posted | Median | Full Range | kg/month | 1 year |
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|
|
|
| Secondary | Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of Treatment) up to 1 Year | The need for escalation of treatment with supraglottoplasty surgery will be assessed through medical chart review up to 1 year. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| Secondary | 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 | The 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the Flexible Laryngoscopy Procedure at the Consult | All 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. | Posted | Count of Participants | Participants | At initial consult |
|
|
|
| Secondary | 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 | Both 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 34 |
| 3 |
| 34 |
| 7 |
| 34 |
| EG001 | 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. | 0 | 31 | 3 | 31 | 8 | 31 |
| Pediatric intensive care unit admission for respiratory distress following supraglottoplasty | Surgical and medical procedures | Systematic Assessment |
|
| Inguinal hernia with incarceration requiring surgery | Reproductive system and breast disorders | Systematic Assessment |
|
| Hospital admission for seizure | Nervous system disorders | Systematic Assessment |
|
| Hospital admission for monitoring post-motor vehicle accident | General disorders | Systematic Assessment |
|
| Emergency department visit eczema and skin yeast infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Emergency department visit viral syndrome | Infections and infestations | Systematic Assessment |
|
| Emergency department visit constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Emergency department post-fall | General disorders | Systematic Assessment |
|
| Emergency department visit abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Emergency department visit tachypnea, fussiness, spitting up | Gastrointestinal disorders | Systematic Assessment |
|
| Emergency department visit seizures | Nervous system disorders | Systematic Assessment |
|
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| D010038 | Otorhinolaryngologic Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| Symptom absent at consult, present at follow-up |
|
| Symptom present at consult and follow-up |
|
| Chest Wall Retractions |
|
| Cyanosis |
|
| Stridor |
|
| Noisy Breathing |
|
| Increased respiratory rate |
|
| Other |
| Stridor pre/post | McNemar | 0.2 | Other |
| Stridor pre/post | McNemar | 0.02 | Superiority |
| Chest wall retractions pre/post | McNemar | 0.5 | Other |
| Chest wall retractions pre/post | McNemar | 1.0 | Other |
| Apnea pre/post | McNemar | 1.0 | Other |
| Symptom absent at consult, present at follow-up |
|
| Symptom present at consult and follow-up |
|
| Choking |
|
| Coughing |
|
| Gagging |
|
| Other |
| Choking pre/post | McNemar | 0.06 | Superiority |
| Choking pre/post | McNemar | 1.0 | Other |
| Coughing pre/post | McNemar | 0.02 | Other |
| Coughing pre/post | Wilcoxon (Mann-Whitney) | 1.0 | Other |
| Gagging pre/post | McNemar | 1.0 | Other |
| Type 3- Posterior collapse of epiglottis |
|