BronchiolitisPhase 1NCT00261937
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
A Phase 1 study of Bronchiolitis, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute bronchiolitis. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Bronchiolitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Dec 2005to Apr 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 0-12 months.
- Infants who are otherwise healthy
- Infants with chronic lung disease of prematurity (BPD) will be included, but will be analyzed separately.
- Parents signed a written informed consent.
Who cannot join
- • Other previous or co-morbidity, specifically: respiratory (other than BPD, like Asthma or Cystic Fibrosis), cardiac or renal disease or anomaly.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Bnai Zion Medical Center and Naharia Galilli Medical Center
Haifa, 31048
About this study
We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- Inhaled Furosemide vs Placebo (Normal Saline)
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Furosemide vs Placebo (Normal Saline)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical respiratory effects
Secondary outcomes (3)
1. The duration of hospitalization
2. Time weaned off oxygen
3. Time to full enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startDec 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Investigators
- Amir Kugelman, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261937
- Sponsor's protocol ID
- 67/05
- Status last verified
- Dec 2005
- First submitted
- 5 Dec 2005
- Last updated
- 6 Feb 2013
- Results posted
- No
Publications
Bar A, Srugo I, Amirav I, Tzverling C, Naftali G, Kugelman A. Inhaled furosemide in hospitalized infants with viral bronchiolitis: a randomized, double-blind, placebo-controlled pilot study. Pediatr Pulmonol. 2008 Mar;43(3):261-7. doi: 10.1002/ppul.20765.
PubMed 18214942
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
- ClinicalTrials.gov ID
- NCT00261937
- Acronym / sponsor ID
- 67/05
- Conditions
- Bronchiolitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Dec 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 6 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 0-12 months.
- Infants who are otherwise healthy
- Infants with chronic lung disease of prematurity (BPD) will be included, but will be analyzed separately.
- Parents signed a written informed consent.
Key exclusion criteria (1 listed)
- • Other previous or co-morbidity, specifically: respiratory (other than BPD, like Asthma or Cystic Fibrosis), cardiac or renal disease or anomaly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Furosemide vs Placebo (Normal Saline) | Drug | – |
Primary outcome
Clinical respiratory effects
3 secondary outcomes
1. The duration of hospitalization
2. Time weaned off oxygen
3. Time to full enteral feeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Results publication: PubMed 18214942Bar A, Srugo I, Amirav I, Tzverling C, Naftali G, Kugelman A. Inhaled furosemide in hospitalized infants with viral bronchiolitis: a randomized, double-blind, placebo-controlled pilot study. Pediatr Pulmonol. 2008 Mar;43(3):261-7. doi: 10.1002/ppul.20765.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Kugelman principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Bronchiolitis, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical respiratory effects. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00261937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.