BronchiolitisNCT03614273
Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis
A study testing Hypertonic saline and Adrenaline in people with Bronchiolitis, run by Maulana Azad Medical College at 1 site in India.
Trial summary
The primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy. 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 Adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2015to 29 Feb 2016
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 month to 2 years with moderate to severe bronchiolitis as per Wang score
Who cannot join
- Comorbidities such as congenital heart disease, bronchopulmonary dysplasia, cystic fibrosis, neurological diseases
- Known or suspected immunodeficiency
- Congenital malformations
- History of use of steroids within one week prior to presentation
- Severe disease requiring admission to intensive care unit/mechanical ventilation
Trial locations and contacts
1 site in 1 country.
India1 site
Maulana Azad Medical College
New Delhi, National Capital Territory of Delhi, 110002
About this study
Official title: Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial
The primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy.
This trial was conducted at a tertiary care teaching hospital over a period of one year in children with bronchiolitis presenting to the out-patient department and emergency. After obtaining a signed informed consent from the parents, all eligible children were assessed for baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial blood gas analysis where ever required.
Read more
Computer generated random numbers were used for enrolment in consecutive manner and patients were randomly assigned into two groups. The first group received one dose (4ml) of nebulized hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing, antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary.
All children were reassessed 20 minutes after one dose of nebulization using the clinical score and a child was labelled as a "responder" if he showed an improvement in the clinical severity score by atleast 3 points after 20 minutes of nebulization. Both responders and non-responders were given a repeat dose of nebulization according to the group to which the child had been randomized, if: a) Severe audible wheeze with severe respiratory distress (severity score ≥9) b) Inability to maintain saturation >92% even on an O2 flow of 4 L/min. Non responders were given a maximum of three continuous doses of nebulization.
Child was considered fit for discharge if he/she was feeding well orally, there was no need for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours.
- Conditions
- Bronchiolitis
- Being tested
- Hypertonic saline, Adrenaline
- Keywords
- nebulization, adrenaline, hypertonic saline, bronchiolitis
- 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
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
AdrenalineDrug
Also called Epinephrine
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (HS) | Active comparator | Nebulized with 4 ml of 3% hypertonic saline for a duration of 20 minutes Receives: Drug: Hypertonic saline |
| Group 2 (Adr) | Active comparator | Nebulized with 0.1 mg/kg of adrenaline (non-racemic solution, 1:1000 concentration), which was diluted in normal saline to make it a 4 ml solution, for a duration of 20 minutes Receives: Drug: Adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
Duration from the time of enrolment to the point at which the discharge criteria (feeding well orally, no need for intravenous fluids, clinical severity score ≤ 3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours) are met.
Measured: During hospitalization, approximately 2 days
Secondary outcomes (5)
Initial change in the Wang bronchiolitis clinical severity score
A decrease in the Wang bronchiolitis clinical severity score by at least 3 points after 20 minutes of nebulization was considered as an improvement in the clinical condition. The Wang score ranges from 0 - 12 [0-4: mild, 5-8: moderate, 9-12: severe].
Measured: 20 minutes after the first nebulization
Number of hours of intravenous fluid requirement
Intravenous fluids were given to children unable to accept orally.
Measured: During hospitalization, approximately 2 days
Number of hours of oxygen requirement
Oxygen was administered when the saturation was less than 92%
Measured: Till the time the child maintained a saturation of more than 94% for at least 4 hours
Number of doses of nebulization needed
Indications for repeat dose were if:
- The child had severe audible wheeze with severe respiratory distress (severity score ≥9)
- The child was not able to maintain saturation >92% even on an oxygen flow of 4 L/min
Measured: During hospitalization, approximately 2 days
Response after each nebulization
An improvement in the clinical severity score by at least 3 points after each nebulization.
Measured: Assessed 20 minutes after each nebulization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Mar 2015
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maulana Azad Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerin C Sekhar, Maulana Azad Medical College
- Investigators
- Jerin C Sekhar, MD, Principal investigator, Maulana Azad Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614273
- Sponsor's protocol ID
- bronchiolitisjer90
- Status last verified
- Aug 2018
- First submitted
- 13 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03614273
- Acronym / sponsor ID
- bronchiolitisjer90
- Conditions
- Bronchiolitis
- Keywords
- nebulization, adrenaline, hypertonic saline, bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maulana Azad Medical CollegeUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 3 Aug 2018 (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.
The primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy.
This trial was conducted at a tertiary care teaching hospital over a period of one year in children with bronchiolitis presenting to the out-patient department and emergency. After obtaining a signed informed consent from the parents, all eligible children were assessed for baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial blood gas analysis where ever required.
Computer generated random numbers were used for enrolment in consecutive manner and patients were randomly assigned into two groups. The first group received one dose (4ml) of nebulized hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing, antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary.
All children were reassessed 20 minutes after one dose of nebulization using the clinical score and a child was labelled as a "responder" if he showed an improvement in the clinical severity score by atleast 3 points after 20 minutes of nebulization. Both responders and non-responders were given a repeat dose of nebulization according to the group to which the child had been randomized, if: a) Severe audible wheeze with severe respiratory distress (severity score ≥9) b) Inability to maintain saturation >92% even on an O2 flow of 4 L/min. Non responders were given a maximum of three continuous doses of nebulization.
Child was considered fit for discharge if he/she was feeding well orally, there was no need for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (HS) | Active comparator | Drug: Hypertonic salineNebulized with 4 ml of 3% hypertonic saline for a duration of 20 minutes |
| Group 2 (Adr) | Active comparator | Drug: AdrenalineNebulized with 0.1 mg/kg of adrenaline (non-racemic solution, 1:1000 concentration), which was diluted in normal saline to make it a 4 ml solution, for a duration of 20 minutes |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 1 month to 2 years with moderate to severe bronchiolitis as per Wang score
Key exclusion criteria (5 listed)
- Comorbidities such as congenital heart disease, bronchopulmonary dysplasia, cystic fibrosis, neurological diseases
- Known or suspected immunodeficiency
- Congenital malformations
- History of use of steroids within one week prior to presentation
- Severe disease requiring admission to intensive care unit/mechanical ventilation
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 salineThe nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min. | Drug | Group 1 (HS) |
| AdrenalineAlso: EpinephrineThe nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min. | Drug | Group 2 (Adr) |
Primary outcome
Duration of hospital stay
Time frame: During hospitalization, approximately 2 days
Duration from the time of enrolment to the point at which the discharge criteria (feeding well orally, no need for intravenous fluids, clinical severity score ≤ 3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours) are met.
5 secondary outcomes
Initial change in the Wang bronchiolitis clinical severity score
Time frame: 20 minutes after the first nebulization
Number of hours of intravenous fluid requirement
Time frame: During hospitalization, approximately 2 days
Number of hours of oxygen requirement
Time frame: Till the time the child maintained a saturation of more than 94% for at least 4 hours
Number of doses of nebulization needed
Time frame: During hospitalization, approximately 2 days
Response after each nebulization
Time frame: Assessed 20 minutes after each nebulization
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 3 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jerin C Sekhar, MD principal investigator
Maulana Azad Medical College
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 Adrenaline in people with Bronchiolitis, run by Maulana Azad Medical College at 1 site in India.
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 5 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 3 Aug 2018. 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 India. 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?
Duration of hospital stay (time frame: During hospitalization, approximately 2 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 3 Aug 2018.