Trial · NCT00435994
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
NCT00435994, Not applicable, Completed, Indiana University; results first posted 2016-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of Airway Obstruction in Infants With Lower Respiratory Infections. Trials, record NCT00435994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00435994
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
- NCT number
- NCT00435994
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 59 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Bronchiolitis, Respiratory Syncytial Virus Infections
- Interventions
- Inhaled primatene will be given as a breathing treatment, Nasal Washing
- First posted
- 2007-02-16
- Last updated
- 2016-06-01
- Results first posted
- 2016-06-01
- Limitations and caveats
- More than half of our infants woke up before completion of the protocol therefore limiting our analysis.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | Endothelial Growth Factor (VEGF) | During nasal wash | Analysis for VEGF level by ELISA |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lung Function | Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes) | 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. | Z score | MEAN |
| PRIMARY | Endothelial Growth Factor (VEGF) | During nasal wash | Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV. | pg/dl | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lung Function | Healthy Control | Baseline | 0.071 | Standard Deviation 0.586 | Z score |
| Lung Function | Respiratory Syncytial Virus | Baseline | -3.179 | Standard Deviation 2.610 | Z score |
| Lung Function | Healthy Control | Post Bronchodilator | 0.186 | Standard Deviation 0.639 | Z score |
| Lung Function | Respiratory Syncytial Virus | Post Bronchodilator | -3.345 | Standard Deviation 2.112 | Z score |
| Lung Function | Healthy Control | Post Epinephrine | 0.041 | Standard Deviation 0.802 | Z score |
| Lung Function | Respiratory Syncytial Virus | Post Epinephrine | -2.430 | Standard Deviation 2.716 | Z score |
| Endothelial Growth Factor (VEGF) | Healthy Control | 183.526 | Standard Deviation 223.268 | pg/dl | |
| Endothelial Growth Factor (VEGF) | Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only | 568.867 | Standard Deviation 407.257 | pg/dl |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Healthy Control | 22 | |
| Overall Study | STARTED | Respiratory Syncytial Virus | 25 | |
| Overall Study | STARTED | Bronchiolitis-Nasal Wash Only | 12 | |
| Overall Study | COMPLETED | Healthy Control | 15 | |
| Overall Study | COMPLETED | Respiratory Syncytial Virus | 25 | |
| Overall Study | COMPLETED | Bronchiolitis-Nasal Wash Only | 12 | |
| Overall Study | NOT COMPLETED | Healthy Control | 7 | |
| Overall Study | NOT COMPLETED | Respiratory Syncytial Virus | 0 | |
| Overall Study | NOT COMPLETED | Bronchiolitis-Nasal Wash Only | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Healthy Control | ||
| Total, all-cause mortality | Respiratory Syncytial Virus | ||
| Total, all-cause mortality | Bronchiolitis | ||
| Total, other adverse events | Healthy Control | 0 | 15 |
| Total, other adverse events | Respiratory Syncytial Virus | 0 | 25 |
| Total, other adverse events | Bronchiolitis | 0 | 12 |
| Total, serious adverse events | Healthy Control | 0 | 15 |
| Total, serious adverse events | Respiratory Syncytial Virus | 0 | 25 |
| Total, serious adverse events | Bronchiolitis | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00435994
GET https://conductscience.org/api/trials/v1/NCT00435994/registered