Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?

NCT03204760 | Unknown Phase 2

• 1 other identifier: Eman Alfy Ellia
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Steroids In Management Of Acute Asthma Exacerbations

Outcome Measures

Primary Outcomes (1)

• The Pediatric Respiratory Assessment Measure (PRAM)

  The Pediatric Respiratory Assessment Measure (PRAM) , a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, appears to be the most appropriate as an application in the emergency care setting . The PRAM score consists of five components and has a maximum total of 12 points: suprasternal retractions (0 to 2), scalene muscle contraction (0 to 2), air entry (0 to 3), wheezing (0 to 3) and O2 saturation (0 to 2) .

  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.

Study Arms (2)

dexamethasone

EXPERIMENTAL

Dexamethasone is a long-acting glucocorticoid with a half-life of 36 to 72 hours . It has been used safely in children with croup and bacterial meningitis . It is well absorbed both orally and parenterally .Single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg).

Drug: Dexamethasone 8Mg Solution for Injection

prednisolone

EXPERIMENTAL

Prednisolone is relatively short acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Outpatient steroid therapy is effective once compliance is assured.. Prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance with prednisolone. Oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses .

Drug: Prednisolone Oral, Per 5 Mg

Interventions

Dexamethasone 8Mg Solution for Injection DRUG

Effect single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) in the treatment of mild to moderate acute asthma exacerbations in children

dexamethasone

Prednisolone Oral, Per 5 Mg DRUG

Effect of prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses in the treatment of mild to moderate acute asthma exacerbations in children.

prednisolone

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

MeSH Terms

Interventions

Dexamethasone; Solutions; Injections; Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Moustafa M. El-Saied, Ph.D.of pediatrics

  Assiut University -Faculty of medecin( Pediaric department)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident pediatrician , Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 2, 2017
• Study Start: January 1, 2017
• Primary Completion: April 30, 2017
• Study Completion: February 28, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)