Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000590864
Ethics application status
Approved
Date submitted
29/05/2012
Date registered
1/06/2012
Date last updated
12/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Prednisolone in Preschool wheeze
Scientific title
In children between age 1 and 5 years with salbutamol responsive wheeze does treatment with prednisolone compared with placebo result in lower PRAM at 24 hours?
Secondary ID [1] 280575 0
Nil
Universal Trial Number (UTN)
Trial acronym
WASP (Wheeze And Steroids in Pre-schooler's)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wheeze in Preschool aged children. 286576 0
Condition category
Condition code
Respiratory 286853 286853 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2mg/kg of prednisolone. Orally, Once Daily for 3 days.
Intervention code [1] 284963 0
Treatment: Drugs
Comparator / control treatment
Placebo, oral placebo formulation, "orabase". Orally, Once daily for 3 days.
Control group
Placebo

Outcomes
Primary outcome [1] 287207 0
The respiratory assessment measure, PRAM .
(PRAM = Preschool Respiratory Assessment Measure)
Timepoint [1] 287207 0
Initial pram assessed at time of arrival in the emergency department.
Second pram Score assessed between 24 - 36 hours following the administration of the study medication.
The Majority of patients will be discharged from the emergency department. They will have a PRAM score assessed in their home by home care nurses between 24 and 36 hours following discharge.
Pateints admitted will have their PRAm score assessed at 24 hours by the nurse caring for them.
Secondary outcome [1] 297632 0
Salbutamol usage.
Parents will be asked how many puffs of salbutamol they have administered to their child using a questionaire. The values collected will be the following:
0-6 puffs
7-12 puffs
13-24 puffs
25-49 puffs
more the 49 puffs
Timepoint [1] 297632 0
24 - 36 hours, the time of the PRAM score assessment.
Secondary outcome [2] 297633 0
Disturbed sleep, parents will be asked about how many extra times their child wake in the previous night using a standard questionnaire:
0, 1 ,2 ,3 or more times
Timepoint [2] 297633 0
24 - 36 hours, the time of the PRAM score assessment.
Secondary outcome [3] 297634 0
visit to doctors: parents will be asked if they have taken their child to a doctor since discharge using a standard questionnaire.
If the answer is yes parents will be asked if this was because the were concerned about their childs breathing.
Timepoint [3] 297634 0
24 - 36 hours, the time of the PRAM score assessment
Secondary outcome [4] 297636 0
Parents perception of their child's health: Parents will be asked how do they feel about their child's condition in a standard questionnaire. The responses are: Better, Same or Worse.
Timepoint [4] 297636 0
24 - 36 hours, the time of the PRAM score assessment
Secondary outcome [5] 297685 0
Adherence to Medication: parents will be asked if they have administered their child's study medication: If the answer is no then they will be asked for a reason. THis is freeform.
Timepoint [5] 297685 0
24 - 36 hours, the time of the PRAM score assessment

Eligibility
Key inclusion criteria
Preschool age.
Presenting with an acute respiratory illness to the Emergency Department of Starship Childrens Hospital.
Wheeze.

A significant clinical response to Salbutamol. This will be asses using a standard scoring measure, The PRAM score.
Minimum age
12 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to be followed up in 20-36 hours.
Corticosteriods in last 7 days.
Chronic respiratory, neurological or cardiac disease.
Contraindication to corticosteriods or allergy to prednisolone.
History consistent with foreign body inhalation.
Current severe disease (i.e. life threatening asthma).
History of life threatening asthma.
Previously randomised to the WASP study.

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)
Preschool patients with wheeze will be identified at triage, by the asigned nurse or medical staff caring for the patient in the emergency department of our tertiary children's hospital.
A PRAM score will be taken prior to the administration of any salbutamol.
Patients will receive standard treatment with salbutamol for wheeze. This is 3 dose of 6 puffs via spacer every 20 minutes. If the PRAM score reduces by 2 points or more then patients will be invited to take part in the study.
If they agree then the treating nurse will select a sequential envelope from a closed box. The card inside has the study number written on it corresponding to a number on the medication bottle.
The study numbers have been randomised to treatment or placebo.
The study cards have been radomised to the envelopes.
The allocation of the study number and the cards to the envelopes are both random.
The nurse then calculates a dose in mls to be administered to the patient this is written on the bottle.
The bottles are identical.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation of study numbers to treatement or placebo was done using the random number generation feature in excel.

The allocation of study number cards to sequential envelopes was done using the random number generation feature in excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2012
Actual
5/06/2012
Date of last participant enrolment
Anticipated
5/09/2012
Actual
20/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4337 0
New Zealand
State/province [1] 4337 0

Funding & Sponsors
Funding source category [1] 285337 0
Charities/Societies/Foundations
Name [1] 285337 0
A+ Auckland ADHB charitable Trust, research grant.
Country [1] 285337 0
New Zealand
Primary sponsor type
Individual
Name
Dr Richard Aickin,
Address
Clinical director Children's health
Starship Children's Hospital
ADHB
Private Bag 92024,
Auckland 1142,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 284190 0
Individual
Name [1] 284190 0
Dr Michael Shepherd
Address [1] 284190 0
Clinical Director Children's Emergency Department
Starship Children's Hospital
ADHB
Private Bag 92024,
Auckland 1142,
New Zealand
Country [1] 284190 0
New Zealand
Other collaborator category [1] 260829 0
Individual
Name [1] 260829 0
Dr Stuart Dalzeil
Address [1] 260829 0
Director of Research Children's Emergency Department
Starship Children's Hospital
ADHB
Private Bag 92024,
Auckland 1142,
New Zealand
Country [1] 260829 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287348 0
Northern X Regional Ethics Committee
Ethics committee address [1] 287348 0
Private Bag 92522
Wellesley St
Auckland 1141
Ethics committee country [1] 287348 0
New Zealand
Date submitted for ethics approval [1] 287348 0
12/01/2012
Approval date [1] 287348 0
12/03/2012
Ethics approval number [1] 287348 0
NTX/12/02/002

Summary
Brief summary
Wheeze in preschool children is the most common cause of admission to hospital in the age group. In older children and adults, oral corticosteroids are proven to be an effective treatment for wheeze (asthma). However a similar treatment effect has not been demonstrated in the preschool population and effective treatment for preschool wheeze has proved to be difficult to find.
There have only been a handful of studies on the clinical effects of corticosteroids (usually prednisolone) in preschool children with wheeze. These have typically been small studies, had some study design problems and have produced conflicting results – some suggesting they work, some suggesting they don’t. So currently no-one knows whether to continue to give preschool children with wheeze steroids. Administrationof steroids preschool wheeze use is included in clinical guidelines in New Zealand and internationally. However current practice varies greatly and often depends on personal presence.
None of the previous trials have measured salbutamol response or used this to guide treatment, although this is currently used by clinicians to help guide treatment. Salbutamol response is an indicator of airway responsiveness and we hypothesise that a positive response is likely to increase the chance of steroids being effective. We aim to determine the clinical effect of oral corticosteroids in salbutamol responsive preschool wheeze
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34233 0
Dr Mike Shepherd
Address 34233 0
Children's Emergency Department Starship Children's Hospital, ADHB Private Bag 92024, Auckland 1142
Country 34233 0
New Zealand
Phone 34233 0
+64 9 3074902
Fax 34233 0
Email 34233 0
[email protected]
Contact person for public queries
Name 17480 0
Dr Dr Owen Sinclair
Address 17480 0
Owen Sinclair, Paediatric Emergency Fellow
Children's Emergency Department
Starship Children's Hospital, ADHB
Private Bag 92024, Auckland 1142
Country 17480 0
New Zealand
Phone 17480 0
+64 (0)21 242 3001
Fax 17480 0
(64 9) 3757055
Email 17480 0
[email protected]
Contact person for scientific queries
Name 8408 0
Dr Dr Owen Sinclair
Address 8408 0
Owen Sinclair, Paediatric Emergency Fellow
Children's Emergency Department
Starship Children's Hospital, ADHB
Private Bag 92024, Auckland 1142
Country 8408 0
New Zealand
Phone 8408 0
+64 (0)21 242 3001
Fax 8408 0
(64 9) 3757055
Email 8408 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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