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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.
We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with viral lower respiratory infections | Other | Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants |
|
| Healthy Control | Other | Healthy infants between the ages of 2-24 month |
|
| Bronchiolitis-Nasal wash only | Other | Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled primatene will be given as a breathing treatment | Drug | While the research subject is sedated an inhaled mist of primatene mist will be given to the patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function | Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function. | Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes) |
| Endothelial Growth Factor (VEGF) | Analysis for VEGF level by ELISA | During nasal wash |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S. Tepper, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Control | Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity |
| FG001 | Respiratory Syncytial Virus | Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI |
| FG002 | Bronchiolitis-Nasal Wash Only | Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Control | Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity |
| BG001 | Respiratory Syncytial Virus | Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Lung Function | Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function. | All participants who had baseline, post bronchodilator and post epinephrine measurements were included. Participants in the Bronchiolitis arm did not have infant pulmonary functions obtained. | Posted | Mean | Standard Deviation | Z score | Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes) |
|
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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 | Healthy Control |
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More than half of our infants woke up before completion of the protocol therefore limiting our analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Tepper, MD, Ph.D. | Indiana University | 317-274-9647 | rtepper@iu.edu |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D017817 | Nasal Lavage Fluid |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Nasal Washing | Other | 1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence |
|
| BG002 | Bronchiolitis | Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only. |
| BG003 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Respiratory Syncytial Virus | Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI |
|
|
|
| Primary | Endothelial Growth Factor (VEGF) | Analysis for VEGF level by ELISA | Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV. | Posted | Mean | Standard Deviation | pg/dl | During nasal wash |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Respiratory Syncytial Virus | 0 | 25 | 0 | 25 |
| EG002 | Bronchiolitis | 0 | 12 | 0 | 12 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D055556 | Nasal Lavage |
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |