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Trial registered on ANZCTR


Registration number
ACTRN12623000580673
Ethics application status
Approved
Date submitted
11/04/2023
Date registered
26/05/2023
Date last updated
26/05/2023
Date data sharing statement initially provided
26/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Normal Saline (0.9% Saline) Vs Normal Saline plus Salbutamol Nebulization for Acute Bronchiolitis: A randomized controlled trial.
Scientific title
Normal Saline (0.9% Saline) Vs Normal Saline Salbutamol Nebulization for Acute Bronchiolitis: A randomized controlled trial.
Secondary ID [1] 309430 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute bronchiolitis 329687 0
Condition category
Condition code
Respiratory 326583 326583 0 0
Other respiratory disorders / diseases
Infection 326950 326950 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Group A – 4ml of 0.9% saline nebulization supervised by a train doctor, at 4 hour interval for a maximum 12 hours duration though a conventional nebulizer with a face tight mask attached to oxygen source with the flow rate of 5L/min. infants will assessed by investigators before and after intervention at 12 hour intervals. Wang et al clinical severity scale will be used for assessing the severity. Length of hospital stay will be measured from admission till the patient is ready to discharge (clinical severity score <3) Drug A: 4ml of 0.9% saline
Other name: normal saline
Procedure: nebulization
Device: conventional nebulizer
Intervention code [1] 325862 0
Treatment: Drugs
Comparator / control treatment
active comparator: group B - 2.5 mg salbutamol plus 4ml 0.9% saline nebulization supervised by a trained doctor, at 4 hours interval for a maximum of 12 hours duration though a conventional nebulizer with a face tight mask attached to oxygen source with the flow rate of 5L/min. infants will assessed by investigators before and after intervention at 12 hour intervals. Wang et al clinical severity scale will be used for assessing the severity. Length of hospital stay will be measured from admission till the patient is ready to discharge (clinical severity score <3)
Drug B: 2.5mg salbutamol
Procedure: nebulization
Device: conventional nebulizer
Control group
Active

Outcomes
Primary outcome [1] 334441 0
1. Length of hospital stay; from admission till the patient is ready to discharge (clinical severity score less than 3)
Discharge criteria will include, oral feeding, no need for supplemental oxygen or intravenous fluids, clinical severity score = 3, respiratory rate less than 31 breath/min and oxygen saturation more than 92% in room here. this data will be assessed from a pre structured proforma
Timepoint [1] 334441 0
infants will assessed by investigators before and after intervention at 12 hour intervals.
Secondary outcome [1] 420635 0
Clinical severity score (wang et al scale clinical severity score less than3)
Timepoint [1] 420635 0
every 12 hourly infant will be assessed for clinical severity score till the patient is ready for discharged

Eligibility
Key inclusion criteria
1.infant 1month to 2 years age
2.both male and female
3.clinical severity score between 1 and 9
4.first episode of bronchiolitis
Minimum age
1 Months
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.prematurity
2.any underlying disease eg cystic fibrosis, cardiac or renal disease.
3.prior history of wheezing
4.asthma, allergic rhinitis, progressive respiratory failure
5.clinical severity score>9.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
There will be no detectable difference in the color, smell, or other physical properties between 0.9 % saline solution and 0.9 % saline plus salbutamol solution
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The infants will be randomly assigned to 1 of 2 experimental groups by using computer generated random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: The sample size is 178with 89 patients in each group by using WHO calculator at 5% significant level and 80% power using mean heart rate to be 99.1± 1.9 in salbutamol plus normal saline group and 98.7± 1.2 for normal saline group from previous study.
Data will be analyzed by using SPSS version 20. Mean standard deviation will be calculated for continuous variables e.g. age. Frequency and percentages will be calculated for qualitative variables like gender. categorical variable will be compared by using the chi-square test. All the continuous variable will be compared using the paired or unpaired t-test as appropriate. A p value < 0.05 will be considered statistically significant. Effect modifiers e.g. age, gender will be controlled through stratification

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2022
Date of last participant enrolment
Anticipated
Actual
30/03/2023
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
178
Accrual to date
Final
178
Recruitment outside Australia
Country [1] 25391 0
Pakistan
State/province [1] 25391 0
khyber pakhtun khwa peshawar

Funding & Sponsors
Funding source category [1] 313625 0
Self funded/Unfunded
Name [1] 313625 0
dr amir muhammad
Country [1] 313625 0
Pakistan
Primary sponsor type
Individual
Name
Dr Amir Muhammad
Address
lady Reading Hospital MTI/ Khyber bazar Peshawar Khyber Pakhtunkhwa Pakistan
postal code: 25000
Country
Pakistan
Secondary sponsor category [1] 315418 0
None
Name [1] 315418 0
Address [1] 315418 0
Country [1] 315418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312797 0
Lady Reading Hospital Medical Teaching Institution Institutional Review Board (IRB)
Ethics committee address [1] 312797 0
lady Reading Hospital MTI/ Khyber bazar Peshawar Khyber Pakhtunkhwa Pakistan
postal code: 25000
Ethics committee country [1] 312797 0
Pakistan
Date submitted for ethics approval [1] 312797 0
16/05/2022
Approval date [1] 312797 0
02/06/2022
Ethics approval number [1] 312797 0
399/LRH/MTI

Summary
Brief summary
The purpose of this study is to compare the efficacy of 0.9%saline and 4 ml of 0.9%saline with 2.5 mg salbutamol nebulization in infants with acute bronchiolitis. Eligible infants are randomized into group A and B. both groups will be treated with fixed regimen. Group A receive 4 ml of 0.9%saline and group B receive 4ml of 0.9%saline with salbutamol nebulization at 6 hours’ interval.

Hypothesis are;
1.there is no difference between 0.9%saline alone and in combination with salbutamol in reducing hospital stay in infants with acute bronchiolitis.
2. 0.9%saline nebulization is more effective and safe alone than in combination with salbutamol in infants with acute bronchiolitis.
Condition or Disease Intervention/Treatment Phase
Acute bronchiolitis Drug: 0.9% saline
Drug: salbutamol
Procedure: nebulization Not applicable

Detail description:
This double blind randomize control trail will be conducted in the department of pediatrics, Lady Reading Hospital MTI/LRH Peshawar after the approval of the hospital ethical committee. Eligible infants will be included in this study and informed consent will be taken from the parents. Clinical severity score will be assessed by using Wang et al score. Investigators will examine in the infants at the time admission and 12 hourly after treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125958 0
A/Prof Dr. Amir Muhammad
Address 125958 0
lady Reading Hospital MTI/ Khyber bazar Peshawar Khyber Pakhtunkhwa Pakistan
postal code: 25000
Country 125958 0
Pakistan
Phone 125958 0
+923125098679
Fax 125958 0
Email 125958 0
[email protected]
Contact person for public queries
Name 125959 0
Amir Muhammad
Address 125959 0
lady Reading Hospital MTI/ Khyber bazar Peshawar Khyber Pakhtunkhwa Pakistan
postal code: 25000
Country 125959 0
Pakistan
Phone 125959 0
+923125098679
Fax 125959 0
Email 125959 0
[email protected]
Contact person for scientific queries
Name 125960 0
Kamran Wajid
Address 125960 0
lady Reading Hospital MTI/ Khyber bazar Peshawar Khyber Pakhtunkhwa Pakistan
postal code: 25000
Country 125960 0
Pakistan
Phone 125960 0
+923159732426
Fax 125960 0
Email 125960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18839Ethical approval    385725-(Uploaded-11-04-2023-19-16-14)-Study-related document.pdf



Results publications and other study-related documents

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