N/A
N=59
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
Bronchiolitis · Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00435994 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Lung Function — 0.071; -3.179; 0.186; -3.345 Z score — p=0.0020
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inhaled primatene will be given as a breathing treatment (Drug); Nasal Washing (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lung Function |
0.071; -3.179; 0.186; -3.345; 0.041; -2.430 | 0.0020 sig |
| PRIMARY Endothelial Growth Factor (VEGF) |
183.526; 568.867 | .0020 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00435994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.