BronchiolitisPhase 4NCT02233985

Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

A Phase 4 study testing 0.9% Sodium Chloride and 3% Sodium Chloride in people with Bronchiolitis and Wheezing, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Completed

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

Official record

Search all trials

Trial summary

Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to severe bronchiolitis. Read more about this study

Who is it for?: Ages 2 to 24 months
Conditions the study is for: Bronchiolitis, Wheezing
What is being tested?: 0.9% Sodium Chloride and 3% Sodium Chloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteMexico
Study dates: Aug 2013to Mar 2017
Phase: Phase 4
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 2 to 24 months
All sexes
No healthy volunteers
Child

Who may be able to join

All pediatric patients aged 2 months to 24 months of age, both genders attending the pediatric emergency service.
With first episode of wheezing associated with respiratory distress and a history of upper respiratory tract infection.
You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu (HSJD) from 6 to 16 at entry points (moderate and severe degree).

Who cannot join

Subjects with a history of previous wheezing, asthma, or who have received bronchodilator treatment before the present illness.
Subjects with chronic lung disease, with heart disease, with congenital or acquired anatomic abnormalities of the airway.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Unidad Medica de Alta Especialidad Bajío No. 48 Hospital de Gineco - Pediatría. Instituto Mexicano del Seguro Social
León, Guanajuato, 37320

Other trials in Mexico

About this study

Official title: A Randomized Trial of Nebulized 3% Hypertonic Saline With Salbutamol in the Treatment of Acute Bronchiolitis in Pediatric Hospital

Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to severe bronchiolitis.

Read the detailed description

Study design: triple-blind, randomized, parallel-controlled prospective study.
Location: Department of pediatric emergencies and pediatric hospitalization of Highly Specialized Medical Unit (HSMU), Hospital of Gynecology-Obstetrics and Pediatrics (HGOP) No. 48, Mexican Institute of Social Security (MISS).
Patients: 64 patients were included; 32 for each group. Patients had between 2 and 24 months of age with a first episode of wheezing associated with respiratory distress and a history of infection of the upper respiratory tract, with moderate to severe degree of respiratory distress according to the Respiratory Distress Scale of Sant Joan de Déu Hospital (SJDH) .
Interventions: the randomly allocated patients received in group I nebulised 0.9% saline with salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours. In group II , hypertonic (3%) saline plus salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours. In both groups, will be performed at baseline Scale SJDH Respiratory Distress and the end of the first 3 sessions, you will have 30 minutes to make the second evaluation and at 4 hours the third at 8 hours and then every 24 hours throughout the hospital stay . The independent variable is the intervention with hypertonic saline 3% and the variable primary outcome will be assessed improvement or cure with Respiratory Distress Scale SJDH and secondary outcome will be the time of hospital stay .
Descriptive statistics of all variables will be reported. T test was used for two independent groups or nonparametric test according to the distribution of the variables to compare the clinical improvement between the groups with the Scale of Respiratory Distress SJDH, as well as to determine whether there is a difference in time of hospital stay between the two study groups. Square test or Fisher exact chi used to compare readmissions for bronchial hyperresponsiveness between the two groups as well as the complications of the disease itself in each study group. Be reported with frequencies and percentages side effects of hypertonic saline 3%. Was considered statistically significant p <0.05. The results with the Number Cruncher Statistical System (NCSS) 2026 statistical program will be discussed.
The sample size was calculated with t-test to compare means of continuous variables, resulting in 26 subjects per group, adjusting for an expected 20% attrition rate, the sample size was expanded to 32 patients per group.

Conditions: Bronchiolitis, Wheezing
Being tested: 0.9% Sodium Chloride, 3% Sodium Chloride
Keywords: bronchiolitis, hypertonic, saline, salbutamol
Medical subject headings: Bronchiolitis, Respiratory Sounds

What participants receive

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

0.9% Sodium ChlorideDrug
Also called 0.9% saline
Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
3% Sodium ChlorideDrug
Also called 3% saline
Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.

Study groups in NCT02233985
Study group	Role	What they receive
Nebulized 0.9% Sodium Chloride	Active comparator	Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay. Receives: Drug: 0.9% Sodium Chloride
Nebulized 3% Sodium Chloride	Experimental	Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay. Receives: Drug: 3% Sodium Chloride

What is being measured

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

Score Respiratory Distress
It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.
Measured: Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours, and every 24 hours during the entire hospital stay, up to 168 hours.
Hours of Hospital Stay
Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
Measured: From the patient's enrollment in the study until hospital discharge or 168 hours.
Hospital Readmission
After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.
Measured: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.
Frequency of Complications of the Disease Itself
The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.
Measured: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.

Timeline

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

Aug 2013Mar 2017

First posted9 Sep 2014 (estimated)
Study startAug 2013
Primary completionMar 2017
Study completionMar 2017

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 (8)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02233985
Sponsor's protocol ID: R-2012-1002-43
Status last verified: Jul 2026
First submitted: 7 May 2014
Last updated: 2 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: We have your membership number social security and personal data such as address and telephone number of the parents.

Publications

Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.
PubMed 21073773
Sharma BS, Gupta MK, Rafik SP. Hypertonic (3%) saline vs 0.93% saline nebulization for acute viral bronchiolitis: a randomized controlled trial. Indian Pediatr. 2013 Aug;50(8):743-7. doi: 10.1007/s13312-013-0216-8. Epub 2012 Dec 5.
PubMed 23502662
Gupta N, Puliyel A, Manchanda A, Puliyel J. Nebulized hypertonic-saline vs epinephrine for bronchiolitis; proof of concept study of cumulative sum (CUSUM) analysis. Indian Pediatr. 2012 Jul;49(7):543-7. doi: 10.1007/s13312-012-0122-5. Epub 2010 Oct 30.
PubMed 22080619
Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulized 5% or 3% hypertonic or 0.9% saline for treating acute bronchiolitis in infants. J Pediatr. 2010 Oct;157(4):630-4, 634.e1. doi: 10.1016/j.jpeds.2010.04.074. Epub 2010 Jun 19.
PubMed 20646715
Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15.
PubMed 20636429
Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196.
PubMed 19884591
Luo Z, Liu E, Luo J, Li S, Zeng F, Yang X, Fu Z. Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. Pediatr Int. 2010 Apr;52(2):199-202. doi: 10.1111/j.1442-200X.2009.02941.x. Epub 2009 Aug 7.
PubMed 19674354
Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22.
PubMed 21352671

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

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
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease

All Bronchiolitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial of Nebulized 3% Hypertonic Saline With Salbutamol in the Treatment of Acute Bronchiolitis in Pediatric Hospital
ClinicalTrials.gov ID: NCT02233985
Acronym / sponsor ID: R-2012-1002-43
Conditions: Bronchiolitis, Wheezing
Keywords: bronchiolitis, hypertonic, saline, salbutamol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Coordinación de Investigación en Salud, MexicoOther government
Study start: Aug 2013
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 9 Sep 2014 (estimated)
Results: Posted 15 Mar 2017

Clinical summary

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

Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to severe bronchiolitis.

Detailed description

Study design: triple-blind, randomized, parallel-controlled prospective study.
Location: Department of pediatric emergencies and pediatric hospitalization of Highly Specialized Medical Unit (HSMU), Hospital of Gynecology-Obstetrics and Pediatrics (HGOP) No. 48, Mexican Institute of Social Security (MISS).
Patients: 64 patients were included; 32 for each group. Patients had between 2 and 24 months of age with a first episode of wheezing associated with respiratory distress and a history of infection of the upper respiratory tract, with moderate to severe degree of respiratory distress according to the Respiratory Distress Scale of Sant Joan de Déu Hospital (SJDH) .
Interventions: the randomly allocated patients received in group I nebulised 0.9% saline with salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours. In group II , hypertonic (3%) saline plus salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours. In both groups, will be performed at baseline Scale SJDH Respiratory Distress and the end of the first 3 sessions, you will have 30 minutes to make the second evaluation and at 4 hours the third at 8 hours and then every 24 hours throughout the hospital stay . The independent variable is the intervention with hypertonic saline 3% and the variable primary outcome will be assessed improvement or cure with Respiratory Distress Scale SJDH and secondary outcome will be the time of hospital stay .
Descriptive statistics of all variables will be reported. T test was used for two independent groups or nonparametric test according to the distribution of the variables to compare the clinical improvement between the groups with the Scale of Respiratory Distress SJDH, as well as to determine whether there is a difference in time of hospital stay between the two study groups. Square test or Fisher exact chi used to compare readmissions for bronchial hyperresponsiveness between the two groups as well as the complications of the disease itself in each study group. Be reported with frequencies and percentages side effects of hypertonic saline 3%. Was considered statistically significant p <0.05. The results with the Number Cruncher Statistical System (NCSS) 2026 statistical program will be discussed.
The sample size was calculated with t-test to compare means of continuous variables, resulting in 26 subjects per group, adjusting for an expected 20% attrition rate, the sample size was expanded to 32 patients per group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nebulized 0.9% Sodium Chloride	Active comparator	Drug: 0.9% Sodium ChlorideSalbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
Nebulized 3% Sodium Chloride	Experimental	Drug: 3% Sodium ChlorideSalbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.

Who may qualify

Ages: 2 to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

All pediatric patients aged 2 months to 24 months of age, both genders attending the pediatric emergency service.
With first episode of wheezing associated with respiratory distress and a history of upper respiratory tract infection.
You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu (HSJD) from 6 to 16 at entry points (moderate and severe degree).

Key exclusion criteria (2 listed)

Subjects with a history of previous wheezing, asthma, or who have received bronchodilator treatment before the present illness.
Subjects with chronic lung disease, with heart disease, with congenital or acquired anatomic abnormalities of the airway.

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
0.9% Sodium ChlorideAlso: 0.9% salineSalbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.	Drug	Nebulized 0.9% Sodium Chloride
3% Sodium ChlorideAlso: 3% salineSalbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.	Drug	Nebulized 3% Sodium Chloride

Primary outcome

Score Respiratory Distress
Time frame: Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours, and every 24 hours during the entire hospital stay, up to 168 hours.
It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.
Hours of Hospital Stay
Time frame: From the patient's enrollment in the study until hospital discharge or 168 hours.
Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
Hospital Readmission
Time frame: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.
After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.
Frequency of Complications of the Disease Itself
Time frame: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.
The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.

Results and safety

Results posted to the registry on 15 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nebulized 3% Sodium Chloride	32	32
Nebulized 0.9% Sodium Chloride	32	32

Primary outcome: Score Respiratory Distress

Time frame: Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours, and every 24 hours during the entire hospital stay, up to 168 hours.. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Hypertonic Saline Solution 3% (HSS 3%) Group n = 32	Saline Solution 0.9% (SS 0.9%) Group n = 32
Basal	7 (6 to 9)	8 (7 to 10)
30 minutes	6 (5 to 7)	8 (8 to 10)
4 hours	5 (3 to 6)	8 (7 to 10)
8 hours	3 (3 to 5)	8 (5 to 9)
12 hours	3 (3 to 4)	7 (6 to 9)
24 hours	–	7 (6 to 9)
48 hours	–	8 (6 to 8)
72 hours	–	6 (4 to 7)

Population analysed: The number of participants analyzed decreased over time because patients who met the discharge criteria (maintaining a mild respiratory distress score for at least 2 hours) were discharged from the hospital. Consequently, no further clinical measurements were taken for these participants, resulting in zero active participants in the 3% HSS group from the 24-hour mark onwards.

Primary outcome: Hours of Hospital Stay

Time frame: From the patient's enrollment in the study until hospital discharge or 168 hours.. Median (Inter-Quartile Range). Unit: hours

Measure	Hypertonic Saline Solution 3% (SHS 3%) n = 32	Saline Solution 0.9% (SS 0.9%) Group n = 32
Value	8.25 (5.18 to 10.5)	40.35 (18.88 to 79.96)

Population analysed: All patients included in the study, underwent measurement of hours of hospital stay from admission to pediatric emergencies to hospital discharge.

Primary outcome: Hospital Readmission

Time frame: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.. Count of participants. Unit: Participants

Measure	Nebulized 0.9% Sodium Chloride n = 32	Nebulized 3% Sodium Chloride n = 32
Value	0	0

Primary outcome: Frequency of Complications of the Disease Itself

Measure	Nebulized 0.9% Sodium Chloride n = 32	Nebulized 3% Sodium Chloride n = 32
Value	0	5

Adverse events

Time frame: From admission to the trial up to 30 days post-discharge. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebulized 3% Sodium Chloride	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Nebulized 0.9% Sodium Chloride	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21073773Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.
Background: PubMed 23502662Sharma BS, Gupta MK, Rafik SP. Hypertonic (3%) saline vs 0.93% saline nebulization for acute viral bronchiolitis: a randomized controlled trial. Indian Pediatr. 2013 Aug;50(8):743-7. doi: 10.1007/s13312-013-0216-8. Epub 2012 Dec 5.
Background: PubMed 22080619Gupta N, Puliyel A, Manchanda A, Puliyel J. Nebulized hypertonic-saline vs epinephrine for bronchiolitis; proof of concept study of cumulative sum (CUSUM) analysis. Indian Pediatr. 2012 Jul;49(7):543-7. doi: 10.1007/s13312-012-0122-5. Epub 2010 Oct 30.
Background: PubMed 20646715Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulized 5% or 3% hypertonic or 0.9% saline for treating acute bronchiolitis in infants. J Pediatr. 2010 Oct;157(4):630-4, 634.e1. doi: 10.1016/j.jpeds.2010.04.074. Epub 2010 Jun 19.
Background: PubMed 20636429Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15.
Background: PubMed 19884591Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196.
Background: PubMed 19674354Luo Z, Liu E, Luo J, Li S, Zeng F, Yang X, Fu Z. Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. Pediatr Int. 2010 Apr;52(2):199-202. doi: 10.1111/j.1442-200X.2009.02941.x. Epub 2009 Aug 7.
Background: PubMed 21352671Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22.
Clinical Practice Guideline on Acute Bronchiolitis, Spanish Guidelines.Link provided by the sponsor.
Individual participant dataSharing planned: No. We have your membership number social security and personal data such as address and telephone number of the parents.

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
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
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.

Gloria P Sosa-Bustamante, MD study director

Unidad Medica de Alta Especialidad No.48. HGP. Instituto Mexicano del Seguro Social

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.9% Sodium Chloride and 3% Sodium Chloride in people with Bronchiolitis and Wheezing, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

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 3 inclusion and 2 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 2 Oct 2026. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2017). 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?

Score Respiratory Distress (time frame: Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours, and every 24 hours during the entire hospital stay, up to 168 hours.). The study lists 4 primary outcomes in all. 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 NCT02233985, which also lists 8 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 2 Oct 2026.