Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000325505
Ethics application status
Approved
Date submitted
15/12/2023
Date registered
25/03/2024
Date last updated
1/09/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Steroid therapy and outcome of parapneumonic effusion in children :a randomized controlled trial
Scientific title
Steroid therapy and outcome of parapneumonic effusion in children :a randomized controlled trial
Secondary ID [1] 311156 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
parapneumonic effusion 332318 0
Condition category
Condition code
Infection 329030 329030 0 0
Other infectious diseases
Respiratory 329652 329652 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
interventional drug dexamethasone, 0.25mg/kg , Intravenous infusion , 6 hourly , for 2 days will be given along with standard treatment(antibiotic therapy)
.it will be prescribed by pediatrician, delivered and monitored by ward nurses.
participants will be allowed to take other drugs/treatments related to the care of their parapneumonic effusion/pneumonia or other comorbidities and it will be recorded.
Intervention code [1] 327597 0
Treatment: Drugs
Comparator / control treatment
standard treatment : Vancomycin intravenous infusion 20 mg/kg ,8 hourly and Ceftriaxone intravenous infusion 75 mg /kg /day 12-24 hourly,given for 7 days .it will be delivered and monitored by ward nurses.
participants will be allowed to take other drugs/treatments related to the care of their parapneumonic effusion/pneumonia or other comorbidities and it will be documented.
Control group
Active

Outcomes
Primary outcome [1] 336842 0
time to recovery of parapneumonic pleural effusion
Timepoint [1] 336842 0
baseline and 72 hours post intervention(dexamethasone) temperature, respiratory rate and amount of effusion on ultrasonography. Temperature and respiratory rate will be monitored 6 hourly for 72 hours after inclusion in the trial while ultrasound assessment will be done twice, initially at time of participation in trial (baseline) and later on 4th day i.e. 72 hours after treatment.
Secondary outcome [1] 429820 0
length of hospital stay
Timepoint [1] 429820 0
from date of recruitment in clinical trial and receiving intervention till discharge from hospital
Secondary outcome [2] 429822 0
progression of simple parapneumonic effusion requiring drainage
Timepoint [2] 429822 0
ultrasound will be done at time of participation in trial (baseline) and 72 hours post treatment/ intervention. However it can be done earlier if there is worsening of respiratory distress and clinical suspicion is of progression in size of effusion.

Eligibility
Key inclusion criteria
Children (2 mo-14 y) admitted for pneumonia (defined as fever >1oo.4 F with cough and chest
radiography showing parenchymal lesion) with pleural effusion.
Minimum age
2 Months
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Immunodeficiency/chronic lung conditions, Hemodynamic instability requiring cardiac / ventilator support ,Allergy to any of the drugs included in study, Contraindications to steroids, children already taking steroid therapy, Known diabetics, Children with comorbid conditions, ,Active tuberculosis, Blood glucose level above 200 mg/dl at time of enrolment

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
lottery method was used to divide into groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
16/04/2024
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
3/10/2024
Actual
Sample size
Target
38
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 26034 0
Pakistan
State/province [1] 26034 0
punjab

Funding & Sponsors
Funding source category [1] 315409 0
University
Name [1] 315409 0
University of child health sciences, The children hospital Lahore
Country [1] 315409 0
Pakistan
Primary sponsor type
University
Name
University of child health sciences,Children hospital Lahore
Address
Children hospital,ferozepur road Lahore
Country
Pakistan
Secondary sponsor category [1] 317473 0
Individual
Name [1] 317473 0
mubeen nazar duggal
Address [1] 317473 0
university of child health sciences children hospital lahore
Country [1] 317473 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314325 0
ethical committee ,university of child health sciences, The children hospital Lahore
Ethics committee address [1] 314325 0
Ethics committee country [1] 314325 0
Pakistan
Date submitted for ethics approval [1] 314325 0
31/10/2023
Approval date [1] 314325 0
14/11/2023
Ethics approval number [1] 314325 0
no-731 / CH-UCHS

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131194 0
Dr Mubeen Nazar Duggal
Address 131194 0
The Children hospital Lahore,University of child health sciences,Ferozepur road,Nishtar town,Lahore,Punjab.postal code54000
Country 131194 0
Pakistan
Phone 131194 0
+9204299230614
Fax 131194 0
+92429923 0358
Email 131194 0
[email protected]
Contact person for public queries
Name 131195 0
Mubeen Nazar Duggal
Address 131195 0
The Children hospital Lahore,University of child health sciences,Ferozepur road,Nishtar town Lahore,Punjab.postal code 54000
Country 131195 0
Pakistan
Phone 131195 0
+9204299230614
Fax 131195 0
+92429923 0358
Email 131195 0
[email protected]
Contact person for scientific queries
Name 131196 0
Mubeen Nazar Duggal
Address 131196 0
The Children hospital Lahore,University of child health sciences,Ferozepur road,Nishtar town Lahore,Punjab.post code 54000
Country 131196 0
Pakistan
Phone 131196 0
+9204299230614
Fax 131196 0
+924299230358
Email 131196 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case by case basis at the discretion of primary sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• patient baseline characteristics age,gender,weight,record no,date of admission and discharge,complains with duration,physical assessment at admission,chest ultrasound findings,evacuation of effusion,recovery time in hours,length of hospitalization

What types of analyses could be done with individual participant data?
• only to achieve aims in approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available immediately following publication and remain available for 5 years after publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approval by principal investigator
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.