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NCT01247064 · ClinicalTrials.gov registry record · Phase 4
Hypertonic Saline for Acute Bronchiolitis
A Phase 4 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT01247064: Completed Phase 4 study, sponsored by Children's Hospital of Philadelphia.
NCT01247064 is a Phase 4 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01247064, a Phase 4 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.
Primary Outcome
The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the
Interventions
- DRUG Nebulized 3% saline
- DRUG Nebulized 0.9% Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT01247064 record still lists
NCT01247064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Nebulized 3% saline is the first listed.
NCT01247064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01247064 about?
NCT01247064 is a clinical study titled "Hypertonic Saline for Acute Bronchiolitis". The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albute...
What is the current status of trial NCT01247064?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2010-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01247064?
The interventions under investigation include: Nebulized 3% saline (DRUG), Nebulized 0.9% Normal Saline (DRUG).
Who is sponsoring clinical trial NCT01247064?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01247064's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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