Bronchiolitis, Respiratory Syncytial Virus Infections
Conditions
Keywords
Infant, Respiratory Syncytial Virus, Bronchiolitis
Brief summary
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.
Detailed description
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.
Interventions
DRUGInhaled primatene will be given as a breathing treatment
While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.
OTHERNasal Washing
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
Sponsors
Thrasher Research Fund
Indiana University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Years
Healthy volunteers
Yes
Inclusion criteria
* Group 1 Infants between 2 and 24 months that are healthy * Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing
Exclusion criteria
* Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity \< 37 weeks, and cannot be in the ICU.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Function | Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes) | 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. |
| Endothelial Growth Factor (VEGF) | During nasal wash | Analysis for VEGF level by ELISA |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Control Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity | 22 |
| 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 | 25 |
| Bronchiolitis Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only. | 12 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 0 | 0 |
Baseline characteristics
| Characteristic | Healthy Control | Total | Bronchiolitis | Respiratory Syncytial Virus |
|---|---|---|---|---|
| Age, Continuous | 13 months STANDARD_DEVIATION 5 | 11 months STANDARD_DEVIATION 6 | 7 months STANDARD_DEVIATION 4 | 7 months STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 22 participants | 59 participants | 12 participants | 25 participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 39 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 25 | 0 / 12 |
| serious Total, serious adverse events | 0 / 15 | 0 / 25 | 0 / 12 |
Outcome results
Primary
Endothelial Growth Factor (VEGF)
Analysis for VEGF level by ELISA
Time frame: During nasal wash
Population: Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | Endothelial Growth Factor (VEGF) | 183.526 pg/dl | Standard Deviation 223.268 |
| Respiratory Syncytial Virus | Endothelial Growth Factor (VEGF) | 568.867 pg/dl | Standard Deviation 407.257 |
p-value: 0.002ANOVA
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.
Time frame: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Control | Lung Function | Baseline | 0.071 Z score | Standard Deviation 0.586 |
| Healthy Control | Lung Function | Post Bronchodilator | 0.186 Z score | Standard Deviation 0.639 |
| Healthy Control | Lung Function | Post Epinephrine | 0.041 Z score | Standard Deviation 0.802 |
| Respiratory Syncytial Virus | Lung Function | Post Bronchodilator | -3.345 Z score | Standard Deviation 2.112 |
| Respiratory Syncytial Virus | Lung Function | Baseline | -3.179 Z score | Standard Deviation 2.61 |
| Respiratory Syncytial Virus | Lung Function | Post Epinephrine | -2.430 Z score | Standard Deviation 2.716 |
p-value: 0.002ANOVA