Length of Hospital StayNCT03143231
Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis
A study testing Normal saline and Hypertonic saline in people with Length of Hospital Stay, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Background: Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Despite the high prevalence and morbidity of bronchiolitis, therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation remains the cornerstone of therapy for these infants. Read more about this study
- Who is it for?
- Ages 15 days to 2 years
- Conditions the study is for
- Length of Hospital Stay
- What is being tested?
- Normal saline and Hypertonic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Mar 2016to 31 May 2017
- Phase
- Interventional
- 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 15 days to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants up to 24 months of age with diagnosis of acute bronchiolitis
- In accordance with 2006 American Academy of Pediatrics (AAP) definition of bronchiolitis,we did not limit to the first episode of wheeze
- Patients with the diagnosis of bronchiolitis
Who cannot join
- Chronic lung or heart disease (hemodynamically significant cardiac disease, chronic lung disease / bronchopulmonary dysplasia requiring diuretics or oxygen)
- Cystic fibrosis, trisomy 21, immunodeficiency / transplant recipient, neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis
Background: Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Despite the high prevalence and morbidity of bronchiolitis, therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation remains the cornerstone of therapy for these infants.
Over the past 2 decades, research on bronchiolitis management has explored the use of nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary clearance, as well as reduce airway edema.
Aim:The aim of this study is to investigate whether the addition of frequently nebulized hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill infants hospitalized with bronchiolitis.
Read the detailed description
The investigators will conduct this prospective double blind randomized clinical trial by comparing between 2 groups of patients with bronchiolitis, first group will receive 3% hypertonic saline and second group will receive 0.9% saline.
Data collection includes:
Name, Age, Mode of delivery, Birth weight, Current weight, Number of sibling, Immunization record, Duration of breast feeding, past medical history including number of wheezy chest, pneumonia, Parents level of education, Presence of Asthma / Allergic rhinitis in family, Pets /Smoke at home)
Using the validated Respiratory Distress Assessment Instrument (RDAI) investigators will assign patients a score before and at the end of treatment.
To prepare 3% sodium chloride, the investigators will dilute 60 ml 20% sodium chloride injection with 500 ml normal saline (NSS) 0.9%.
Length of stay will be measured in both groups, to establish the efficacy of hypertonic saline in reducing length of stay.
- Conditions
- Length of Hospital Stay
- Being tested
- Normal saline, Hypertonic saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineOther
The normal saline will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.
Hypertonic salineOther
The mixture (500 ml Sodium Chloride 0.9% with 60 ml Sodium chloride 20%) will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Experimental | Sodium Chloride 0.9% will be provided Receives: Other: Normal saline |
| Hypertonic saline | Experimental | 500 ml Sodium Chloride 0.9% with 60 ml Sodium Chloride 20% will be provided Receives: Other: Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
from date of admission to discharge date
Measured: an average of 5 days
Secondary outcomes (2)
transfer to pediatric intensive care unit (PICU)
admission to PICU
Measured: an average of 3 days
use of mechanical ventilator
clinical worsening of patients requiring mechanical ventilator
Measured: an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Mar 2016
- Primary completion30 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Length of Hospital StayStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Rajab, Makassed General Hospital
- Investigators
- Mariam Rajab, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143231
- Sponsor's protocol ID
- 1682016
- Status last verified
- Jun 2017
- First submitted
- 21 Apr 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis
- ClinicalTrials.gov ID
- NCT03143231
- Acronym / sponsor ID
- 1682016
- Conditions
- Length of Hospital Stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 8 May 2017 (actual)
- 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.
Background: Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Despite the high prevalence and morbidity of bronchiolitis, therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation remains the cornerstone of therapy for these infants.
Over the past 2 decades, research on bronchiolitis management has explored the use of nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary clearance, as well as reduce airway edema.
Aim:The aim of this study is to investigate whether the addition of frequently nebulized hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill infants hospitalized with bronchiolitis.
Detailed description
The investigators will conduct this prospective double blind randomized clinical trial by comparing between 2 groups of patients with bronchiolitis, first group will receive 3% hypertonic saline and second group will receive 0.9% saline.
Data collection includes:
Name, Age, Mode of delivery, Birth weight, Current weight, Number of sibling, Immunization record, Duration of breast feeding, past medical history including number of wheezy chest, pneumonia, Parents level of education, Presence of Asthma / Allergic rhinitis in family, Pets /Smoke at home)
Using the validated Respiratory Distress Assessment Instrument (RDAI) investigators will assign patients a score before and at the end of treatment.
To prepare 3% sodium chloride, the investigators will dilute 60 ml 20% sodium chloride injection with 500 ml normal saline (NSS) 0.9%.
Length of stay will be measured in both groups, to establish the efficacy of hypertonic saline in reducing length of stay.
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 |
|---|---|---|
| Normal saline | Experimental | Other: Normal salineSodium Chloride 0.9% will be provided |
| Hypertonic saline | Experimental | Other: Hypertonic saline500 ml Sodium Chloride 0.9% with 60 ml Sodium Chloride 20% will be provided |
Who may qualify
- Ages
- 15 days to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants up to 24 months of age with diagnosis of acute bronchiolitis
- In accordance with 2006 American Academy of Pediatrics (AAP) definition of bronchiolitis,we did not limit to the first episode of wheeze
- Patients with the diagnosis of bronchiolitis
Key exclusion criteria (2 listed)
- Chronic lung or heart disease (hemodynamically significant cardiac disease, chronic lung disease / bronchopulmonary dysplasia requiring diuretics or oxygen)
- Cystic fibrosis, trisomy 21, immunodeficiency / transplant recipient, neuromuscular disease
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 |
|---|---|---|
| Normal salineThe normal saline will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial. | Other | Normal saline |
| Hypertonic salineThe mixture (500 ml Sodium Chloride 0.9% with 60 ml Sodium chloride 20%) will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial. | Other | Hypertonic saline |
Primary outcome
Length of stay
Time frame: an average of 5 days
from date of admission to discharge date
2 secondary outcomes
transfer to pediatric intensive care unit (PICU)
Time frame: an average of 3 days
use of mechanical ventilator
Time frame: an average of 3 days
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 12 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Mariam Rajab, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline and Hypertonic saline in people with Length of Hospital Stay, run by Makassed General Hospital at 1 site in Lebanon.
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 12 Jun 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 Lebanon. 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?
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?
Length of stay (time frame: an average of 5 days). 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 12 Jun 2017.