BronchiolitisHypertonicNCT01238848

Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

A study testing Hypertonic saline and Normal saline in people with Bronchiolitis, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome. Read more about this study

Who is it for?: Ages 1 month to 2 years
Conditions the study is for: Bronchiolitis
What is being tested?: Hypertonic saline and Normal saline
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteArgentina
Study dates: Dec 2010to May 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 month to 2 years
All sexes
No healthy volunteers
Child

Who may be able to join

Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Who cannot join

Chronic respiratory or cardiovascular disease, respiratory failure.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Hospital General de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., C1270AAN

Other trials in Argentina

About this study

Official title: A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis

Read the detailed description

Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.

The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.

Conditions: Bronchiolitis
Being tested: Hypertonic saline, Normal saline
Keywords: Hypertonic, Saline, Bronchiolitis, Efficacy
Medical subject headings: Bronchiolitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hypertonic salineDrug
Also called ClNa 3% (sodium chloride 3%)
3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
Normal salineDrug
Also called ClNa 0.9% (sodium chloride 0.9%)
3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Study groups in NCT01238848
Study group	Role	What they receive
Hypertonic	Experimental	Nebulized hypertonic saline (sodium chloride 3%) + albuterol Receives: Drug: Hypertonic saline
Normal	Active comparator	Normal saline (sodium chloride 0.9%) + albuterol Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Hospitalization Days
hospitalization days
Measured: Participants will be followed for the duration of hospitalization, an expected average of 4 days

Secondary outcomes (1)

Length of Oxygen Use
Length of oxygen use (days)
Measured: Participants will be followed for the duration of hospitalization, an expected average of 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010May 2012

First posted11 Nov 2010 (estimated)
Study startDec 2010
Primary completionOct 2011
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01238848
Sponsor's protocol ID: HGNPE-14-2010
Acronym: Hypertonic
Status last verified: Jul 2012
First submitted: 9 Nov 2010
Last updated: 10 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.
PubMed 18843717
Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
PubMed 20713480
Zhang L, Mendoza-Sassi RA, Wainwright CE, Aregbesola A, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2023 Apr 4;4(4):CD006458. doi: 10.1002/14651858.CD006458.pub5.
PubMed 37014057

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bronchiolitis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis
ClinicalTrials.gov ID: NCT01238848
Acronym / sponsor ID: Hypertonic / HGNPE-14-2010
Conditions: Bronchiolitis
Keywords: Hypertonic, Saline, Bronchiolitis, Efficacy
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
Study start: Dec 2010
Primary completion: Oct 2011 (actual)
Study completion: May 2012 (actual)
First posted: 11 Nov 2010 (estimated)
Results: Posted 17 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hypertonic	Experimental	Drug: Hypertonic salineNebulized hypertonic saline (sodium chloride 3%) + albuterol
Normal	Active comparator	Drug: Normal salineNormal saline (sodium chloride 0.9%) + albuterol

Who may qualify

Ages: 1 month to 2 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Key exclusion criteria (1 listed)

Chronic respiratory or cardiovascular disease, respiratory failure.

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
Hypertonic salineAlso: ClNa 3% (sodium chloride 3%)3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days	Drug	Hypertonic
Normal salineAlso: ClNa 0.9% (sodium chloride 0.9%)3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days	Drug	Normal

Primary outcome

Hospitalization Days
Time frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days
hospitalization days

1 secondary outcome

Length of Oxygen Use
Time frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days

Results and safety

Results posted to the registry on 17 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hypertonic	50	37
Normal	50	45

Primary outcome: Hospitalization Days

Time frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days. Median (Standard Deviation). Unit: days

Measure	Hypertonic n = 37	Normal n = 45
Value	5.8 (2.7)	5.47 (2.1)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hypertonic	0 of 50 (0%)	0 of 50 (0%)	Not reported
Normal	0 of 50 (0%)	0 of 50 (0%)	Not reported

Limitations and caveats (from the sponsor): The initially estimated sample size was not achieved

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18843717Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.
Background: PubMed 20713480Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
Derived from this study: PubMed 37014057Zhang L, Mendoza-Sassi RA, Wainwright CE, Aregbesola A, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2023 Apr 4;4(4):CD006458. doi: 10.1002/14651858.CD006458.pub5.

Related trials for Bronchiolitis

Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Not yet recruiting
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Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
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Aphasia, Stroke
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease

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.

Maria I Espelt, MD principal investigator

Hospital General de Niños Pedro de Elizalde

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hypertonic saline and Normal saline in people with Bronchiolitis, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.

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 1 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 10 Feb 2017. 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 Argentina. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hospitalization Days (time frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days). 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 NCT01238848, which also lists 3 linked publications.

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 10 Feb 2017.