Clinical trial NCT03204760: Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?
Official title: Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Steroids In Management Of Acute Asthma Exacerbations
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children with mild to moderate asthma exacerbation will be given the first dose of salbutamol and will be reassessed after 20 min by the emergency department attending. If further salbutamol is needed, subjects automatically will receive the second dose 20 min apart and receive either single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) or prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses .

A repeat physical examination will be performed, including oxygen saturation, vital signs, PRAM, PEFR after the 3rd dose of salbutamol and at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores. Patient compliance to prednisolone therapy for three days will be also recorded.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of a single dose of intramuscular dexamethasone versus 3 days of twice-daily oral prednisolone in the management of mild to moderate asthma exacerbations in children and test whether this single dose of intramuscular dexamethasone 0.6 mg/kg (max. 18 mg) is equal to prednisolone 1 mg/kg/day (max. 40 mg) in the treatment of exacerbations of asthma in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM).

Detailed description: This study will be performed in Assiut university Children Hospital and will include patients with asthma exacerbations presented to the emergency department for three months. All children presenting to the emergency department with mild to moderate asthma exacerbations will be assessed to decide if the child needs treatment with salbutamol. Before starting treatment the Pediatric Respiratory Assessment Measure (PRAM), vital signs, and oxygen saturation will be recorded. Peak expiratory flow rate (PEFR) will also be recorded if the patient was 6 years or older.

Children with mild to moderate asthma exacerbation will be given the first dose of salbutamol and will be reassessed after 20 min by the emergency department attending. If further salbutamol is needed, subjects automatically will receive the second dose 20 min apart and receive either single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) or oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally .

A repeat physical examination will be performed, including oxygen saturation, vital signs, PRAM, PEFR after the 3rd dose of salbutamol and at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores. Patient compliance to prednisolone therapy for three days will be also recorded.

This study will be performed in Pediatric hospital - Assiut university and will include patients with asthma exacerbations presented to the emergency department for three months.

Eligibility criteria: Inclusion Criteria:

* Ages 2 to 16 years
* Background history of asthma
* Presentation with an asthma exacerbation requiring repeated salbutamol after 20 minutes.

Exclusion Criteria:

* Less than 2 years old or over 16 years
* Critical or life-threatening asthma
* Known tuberculosis exposure
* Active varicella or herpes simplex infection
* Documented concurrent infection with Respiratory syncytial virus
* Fever \>39.5°C
* Use of oral corticosteroids in the previous four weeks
* Concurrent stridor
* Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric

Primary outcomes:
measure: The Pediatric Respiratory Assessment Measure (PRAM)
timeFrame: PRAM score is assessed at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores.
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University -Faculty of medecin( Pediaric department)
name: Moustafa M. El-Saied, Ph.D.of pediatrics
role: STUDY_CHAIR
References: