Respiratory Distress ScoreNCT03814954
Nebulized Epinephrine vs. Salbutamol in Bronchiolitis Among Children
A study testing Salbutamol and Epinephrine in people with Respiratory Distress Score, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent… Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Respiratory Distress Score
- What is being tested?
- Salbutamol and Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2019to 31 Aug 2021
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with acute bronchiolitis.
Who cannot join
- Children with congenital heart disease or
- chronic lung diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months
Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. Nebulized epinephrine showed more efficacy than nebulized salbutamol.
Read the detailed description
The objective of this study is to determine if nebulized epinephrine is more efficacious than nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included in the study.
Children who meet the inclusion criteria will be alternately distributed in two groups:
Group 1:
Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
Group 2:
Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted patients will receive aerosol every 20 minutes three times and after, depending on the clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at the admission if oxygen saturation is below 94% till the normalization of the oxygen saturation.
Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24 hours until they are discharged.
- Conditions
- Respiratory Distress Score
- Being tested
- Salbutamol, Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status
EpinephrineDrug
At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol | Active comparator | Patients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer. Receives: Drug: Salbutamol |
| Epinephrine | Experimental | Patients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Patients hospitalization duration will be recorded
Measured: 5 days
Secondary outcomes (1)
Respiratory distress scoring
The score will be measured through Silverman-Andersen Retraction scoring. The minimum score is 0 indicating no distress. The maximum score is 10 indicating severe respiratory distress
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Jan 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress ScoreStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 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
- NCT03814954
- Sponsor's protocol ID
- 1812182
- Status last verified
- Aug 2022
- First submitted
- 21 Jan 2019
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Epinephrine Versus Nebulized Salbutamol in Bronchiolitis Among Children Aged 1month-24months
- ClinicalTrials.gov ID
- NCT03814954
- Acronym / sponsor ID
- 1812182
- Conditions
- Respiratory Distress Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 24 Jan 2019 (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.
Acute bronchiolitis, mostly secondary to infection due to Respiratory syncytial virus (RSV) is very common in infants under two years old. It is usually benign. However, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. Nebulized epinephrine showed more efficacy than nebulized salbutamol.
Detailed description
The objective of this study is to determine if nebulized epinephrine is more efficacious than nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of bronchiolitis. A randomized clinical trial which recruits children admitted to the pediatrics department with diagnosis of bronchiolitis. Children aged 1 month to 2 years will be included in the study.
Children who meet the inclusion criteria will be alternately distributed in two groups:
Group 1:
Will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer.
Group 2:
Will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. All admitted patients will receive aerosol every 20 minutes three times and after, depending on the clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at the admission if oxygen saturation is below 94% till the normalization of the oxygen saturation.
Clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24 hours until they are discharged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol | Active comparator | Drug: SalbutamolPatients will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer. |
| Epinephrine | Experimental | Drug: EpinephrinePatients will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children diagnosed with acute bronchiolitis.
Key exclusion criteria (2 listed)
- Children with congenital heart disease or
- chronic lung diseases
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 |
|---|---|---|
| SalbutamolAt first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status | Drug | Salbutamol |
| EpinephrineAt first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status | Drug | Epinephrine |
Primary outcome
Length of stay
Time frame: 5 days
Patients hospitalization duration will be recorded
1 secondary outcome
Respiratory distress scoring
Time frame: 5 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 30 Aug 2022.
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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 Salbutamol and Epinephrine in people with Respiratory Distress Score, 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 1 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 30 Aug 2022. 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: 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 30 Aug 2022.