Acute Bronchiolitis Due to Respiratory Syncytial VirusPhase 3childrenNCT06267118
Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis
A Phase 3 study testing Hypertonic Saline Solution, 1 Ml and Adrenaline in people with Acute Bronchiolitis Due to Respiratory Syncytial Virus, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients 1. Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis 2. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Acute Bronchiolitis Due to Respiratory Syncytial Virus
- What is being tested?
- Hypertonic Saline Solution, 1 Ml and Adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 31 Dec 2024
- 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 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children admitted in PICU with acute bronchiolitis
Who cannot join
- children with co-exiting illnesses like
- Congenital Heart Disease
- Immunodeficiency
- other Infectious disease like Meningitis, encephalitis, Pneumonia, TORCH
- Kidneys or liver problem
- Seizures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Combined Military Hospital
Nowshera, KPK, 24110
Syed Qamar Zaman, 00923365307823, dr.qamarzaman@hotmail.com
Shahid Mahmud, 00923315301289, childspec@hotmail.com
About this study
Official title: A Randomized Controlled Trial on the Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis in Children
The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients
- Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis
- Length of Hospitalization
Read the detailed description
This is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in Pediatrics department Combined Military Hospital Nowshera. Patients will be divided into two groups randomly. Group I patients will be nebulized with drug adrenaline every 6 hours and group II patients will be nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, researchers will record WDF score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. All data will be recorded on a research Performa including length of hospital stay. Data will be entered on SPSS to calculate results. Independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. P value less than 0.05 will be considered as significant.
- Being tested
- Hypertonic Saline Solution, 1 Ml, Adrenaline
- Keywords
- Wood-Downes Clinical scoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic Saline Solution, 1 MlDrug
Also called Drug A
Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization
AdrenalineDrug
Also called Drug B
dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline nebulization group | Active comparator | First group of patients diagnosed as acute bronchiolitis will be nebulized with hypertonic saline every 6 hours and data will be recorded on a Performa Receives: Drug: Hypertonic Saline Solution, 1 Ml |
| Adrenaline nebulization group | Active comparator | Second group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa Receives: Drug: Adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wood-Downes-Ferres clinical score calculation
A score of 0-3 mild, 4-6 moderately ill, >6 severely ill
Measured: at 24 and 48 hours of treatment
Secondary outcomes (1)
total length of hospitalization
less than 1 week, more than 1 week,
Measured: less than 7 days, 7-10 days, 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Nov 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Bronchiolitis Due to Respiratory Syncytial VirusStudies 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
- Model description
- Patients with acute bronchiolitis after informed written consent will be divided into two groups randomly. Group I will be nebulized with adrenaline every 6 hours and group II will nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, WDF score will be recorded by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. Researcher will record all data on a specified Performa.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Qamar Zaman, Combined Military Hospital, Pakistan
- Investigators
- Prof Shahid Mahmud, Study director, Military Hospital Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267118
- Sponsor's protocol ID
- Treatment of Bronchiolitis
- Acronym
- children
- Status last verified
- Aug 2024
- First submitted
- 7 Jan 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After informed consent of participants and ethical committee approval, it will be shared.
Publications
Piedimonte G, Perez MK. Respiratory syncytial virus infection and bronchiolitis. Pediatr Rev. 2014 Dec;35(12):519-30. doi: 10.1542/pir.35-12-519. No abstract available.
PubMed 25452661Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. Pediatr Pulmonol. 2010 Jan;45(1):41-7. doi: 10.1002/ppul.21108.
PubMed 19953579Florin TA, Plint AC, Zorc JJ. Viral bronchiolitis. Lancet. 2017 Jan 14;389(10065):211-224. doi: 10.1016/S0140-6736(16)30951-5. Epub 2016 Aug 20.
PubMed 27549684Grewal 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 19884591Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2017 Dec 21;12(12):CD006458. doi: 10.1002/14651858.CD006458.pub4.
PubMed 29265171Hariprakash S, Alexander J, Carroll W, Ramesh P, Randell T, Turnbull F, Lenney W. Randomized controlled trial of nebulized adrenaline in acute bronchiolitis. Pediatr Allergy Immunol. 2003 Apr;14(2):134-9. doi: 10.1034/j.1399-3038.2003.00014.x.
PubMed 12675760Fretzayas A, Moustaki M. Etiology and clinical features of viral bronchiolitis in infancy. World J Pediatr. 2017 Aug;13(4):293-299. doi: 10.1007/s12519-017-0031-8. Epub 2017 May 4.
PubMed 28470580
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis in Children
- ClinicalTrials.gov ID
- NCT06267118
- Acronym / sponsor ID
- children / Treatment of Bronchiolitis
- Keywords
- Wood-Downes Clinical scoring System
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (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 goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients
- Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis
- Length of Hospitalization
Detailed description
This is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in Pediatrics department Combined Military Hospital Nowshera. Patients will be divided into two groups randomly. Group I patients will be nebulized with drug adrenaline every 6 hours and group II patients will be nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, researchers will record WDF score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. All data will be recorded on a research Performa including length of hospital stay. Data will be entered on SPSS to calculate results. Independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. P value less than 0.05 will be considered as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients with acute bronchiolitis after informed written consent will be divided into two groups randomly. Group I will be nebulized with adrenaline every 6 hours and group II will nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, WDF score will be recorded by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. Researcher will record all data on a specified Performa.
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline nebulization group | Active comparator | Drug: Hypertonic Saline Solution, 1 MlFirst group of patients diagnosed as acute bronchiolitis will be nebulized with hypertonic saline every 6 hours and data will be recorded on a Performa |
| Adrenaline nebulization group | Active comparator | Drug: AdrenalineSecond group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children admitted in PICU with acute bronchiolitis
Key exclusion criteria (6 listed)
- children with co-exiting illnesses like
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 Saline Solution, 1 MlAlso: Drug ADilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization | Drug | Hypertonic saline nebulization group |
| AdrenalineAlso: Drug Bdilute 0.3 ml adrenaline with 3 ml normal saline for nebulization | Drug | Adrenaline nebulization group |
Primary outcome
Wood-Downes-Ferres clinical score calculation
Time frame: at 24 and 48 hours of treatment
A score of 0-3 mild, 4-6 moderately ill, >6 severely ill
1 secondary outcome
total length of hospitalization
Time frame: less than 7 days, 7-10 days, 10-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Results publication: PubMed 25452661Piedimonte G, Perez MK. Respiratory syncytial virus infection and bronchiolitis. Pediatr Rev. 2014 Dec;35(12):519-30. doi: 10.1542/pir.35-12-519. No abstract available.
- Results publication: PubMed 19953579Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. Pediatr Pulmonol. 2010 Jan;45(1):41-7. doi: 10.1002/ppul.21108.
- Results publication: PubMed 27549684Florin TA, Plint AC, Zorc JJ. Viral bronchiolitis. Lancet. 2017 Jan 14;389(10065):211-224. doi: 10.1016/S0140-6736(16)30951-5. Epub 2016 Aug 20.
- Results publication: 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.
- Results publication: PubMed 29265171Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2017 Dec 21;12(12):CD006458. doi: 10.1002/14651858.CD006458.pub4.
- Results publication: PubMed 12675760Hariprakash S, Alexander J, Carroll W, Ramesh P, Randell T, Turnbull F, Lenney W. Randomized controlled trial of nebulized adrenaline in acute bronchiolitis. Pediatr Allergy Immunol. 2003 Apr;14(2):134-9. doi: 10.1034/j.1399-3038.2003.00014.x.
- Results publication: PubMed 28470580Fretzayas A, Moustaki M. Etiology and clinical features of viral bronchiolitis in infancy. World J Pediatr. 2017 Aug;13(4):293-299. doi: 10.1007/s12519-017-0031-8. Epub 2017 May 4.
- RCTnebulized epinephrine versus nebulized hypertonic saline in infants with acute bronchiolitisLink provided by the sponsor.
- Viral bronchiolitis in children: A common condition with few therapeutic optionsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. After informed consent of participants and ethical committee approval, it will be shared.
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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.
Prof Shahid Mahmud study director
Military Hospital Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypertonic Saline Solution, 1 Ml and Adrenaline in people with Acute Bronchiolitis Due to Respiratory Syncytial Virus, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
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 6 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syed Qamar Zaman (00923365307823, dr.qamarzaman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wood-Downes-Ferres clinical score calculation (time frame: at 24 and 48 hours of treatment). 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 NCT06267118, which also lists 7 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 22 Aug 2024.