BronchiolitisPhase 3NCT02162745
Nasal Irrigation in Infants With Bronchiolitis.
A Phase 3 study testing Isotonic solution (NaCl 0.9%) and Hypertonic solution (NaCl 3%) in people with Bronchiolitis, run by IRCCS Burlo Garofolo at 2 sites in Italy.
Trial summary
Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration. Read more about this study
- Who is it for?
- Ages 1 day to 365 days
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Isotonic solution (NaCl 0.9%) and Hypertonic solution (NaCl 3%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2012to May 2014
- Phase
- Phase 3
- 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 365 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants <1 year
- diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
- oxygen saturation between 88 and 94%
Who cannot join
- previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
- chronic illness
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli
Pordenone, Friuli Venezia Giulia, 33170
Emergency Department, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, 34137
About this study
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis
Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration.
Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out.
The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.
- Conditions
- Bronchiolitis
- Being tested
- Isotonic solution (NaCl 0.9%), Hypertonic solution (NaCl 3%)
- Keywords
- Bronchiolitis, Normal saline solution, Hypertonic solution, Nasal irrigation
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic solution (NaCl 0.9%)Drug
Hypertonic solution (NaCl 3%)Drug
| Study group | Role | What they receive |
|---|---|---|
| Isotonic solution (NaCl 0.9%) | Experimental | Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril Receives: Drug: Isotonic solution (NaCl 0.9%) |
| Hypertonic solution (NaCl 3%) | Experimental | Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril Receives: Drug: Hypertonic solution (NaCl 3%) |
| Supportive care | No intervention | Wiping the nose, positioning the child, changing a wet diaper, feeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation (%)
Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter
Measured: up to 50 minutes after allocation
Secondary outcomes (1)
Respiratory effort (WARME score)
Evaluation of the respiratory effort using the validated WARME score (evaluation of: 1) respiratory rate; 2) prolonged expiration; 2) wheezing; 3) air exchange; 4) muscle use).
Measured: 5, 15, 20, 50 minutes after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Dino Barbi, MD, Study chair, IRCCS Burlo Garofolo, Trieste, ItalySilvana Schreiber, RN, Study director, IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162745
- Sponsor's protocol ID
- RC 35/12
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis
- ClinicalTrials.gov ID
- NCT02162745
- Acronym / sponsor ID
- RC 35/12
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Normal saline solution, Hypertonic solution, Nasal irrigation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Jun 2014 (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.
Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration.
Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out.
The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isotonic solution (NaCl 0.9%) | Experimental | Drug: Isotonic solution (NaCl 0.9%)Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril |
| Hypertonic solution (NaCl 3%) | Experimental | Drug: Hypertonic solution (NaCl 3%)Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril |
| Supportive care | No intervention | –Wiping the nose, positioning the child, changing a wet diaper, feeding. |
Who may qualify
- Ages
- 1 day to 365 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- infants <1 year
- diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
- oxygen saturation between 88 and 94%
Key exclusion criteria (2 listed)
- previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
- chronic illness
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 |
|---|---|---|
| Isotonic solution (NaCl 0.9%) | Drug | Isotonic solution (NaCl 0.9%) |
| Hypertonic solution (NaCl 3%) | Drug | Hypertonic solution (NaCl 3%) |
Primary outcome
Oxygen saturation (%)
Time frame: up to 50 minutes after allocation
Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter
1 secondary outcome
Respiratory effort (WARME score)
Time frame: 5, 15, 20, 50 minutes after allocation
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 13 Jun 2014.
Related trials for Bronchiolitis
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
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.
Dino Barbi, MD study chair
IRCCS Burlo Garofolo, Trieste, Italy
Silvana Schreiber, RN study director
IRCCS Burlo Garofolo, Trieste, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isotonic solution (NaCl 0.9%) and Hypertonic solution (NaCl 3%) in people with Bronchiolitis, run by IRCCS Burlo Garofolo at 2 sites in Italy.
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 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Oxygen saturation (%) (time frame: up to 50 minutes after allocation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2014; AzTrials last refreshed its copy on 1 Nov 2026.