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Steroid Therapy in Acute Bronchiolitis A New Old Line of Therapy.

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03436225
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
Marina shohdy dous, Assiut University

Brief Summary:
The aim of the present study is to evaluate the efficacy of steroid therapy and hospital stay in patients with acute bronchiolitis at assiut university children hospital.

Condition or disease Intervention/treatment Phase
Bronchiolitis; Respiratory Syncytial Virus Drug: Dexamethasone orally. Drug: Dexamethasone parenteral. Drug: Inhaled nebulized Budesonide. Drug: Inhaled nebulized salbutamol. Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Steroid Therapy in Acute Bronchiolitis A New Old Line of Therapy.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Group one
Group one will receive dexamethasone orally (0.15mg /kg / dose) twice daily for 3 to 5 days.
Drug: Dexamethasone orally.
Administered orally (0.15mg /kg / dose) twice daily for 3 to 5 days.
Other Names:
  • Apidone syrup.
  • Phenadone syrup.

Group two
Group two will receive dexamethasone parenteral (0.15mg /kg /dose) twice daily for 3 to 5 days.
Drug: Dexamethasone parenteral.
Administered parenteral (0.15mg /kg / dose) twice daily for 3 to 5 days.
Other Name: Fortecortin 8 mg /2 ml ampoule i.v /i.m injection .

Group three
Group three will receive inhaled nebulized budesonide (1 mg/2ml) twice daily for 3 to 5 days.
Drug: Inhaled nebulized Budesonide.
Administered for inhalation (1 mg/ 2ml) twice daily for 3 to 5 days.
Other Name: Pulmicorte respules1 mg /2 ml.

Group four
Group four will receive symptomatic treatment in form of inhaled nebulized salbutamol(0.15mg/kg/ dose) daily every 6-8 hours.
Drug: Inhaled nebulized salbutamol.
Administered for inhalation (0.15mg /kg / dose) daily every 6-8hrs
Other Name: Farcoline respirator 0,5% solution.

Primary Outcome Measures :
  1. Resolution of respiratory distress. [ Time Frame: <7 days ]
    A total clinical score ≤ 3 and oxygen saturation ≥ 95 % at room air together with respiratory score of 0 or 1, a wheezing score of 0 or 1, and a retraction muscle score of 0 or 1

Secondary Outcome Measures :
  1. Reduction of mean duration of symptoms. [ Time Frame: <7 days ]
    Improvement of respiratory symptoms within fewer days .

  2. Reduction of duration of oxygen therapy. [ Time Frame: <7 days ]
    Reduction the need for more oxygen therapy .

  3. Reduction of average Length of hospital stay. [ Time Frame: <7 days ]
    Decrease Length of hospital stay.

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Ages Eligible for Study:   3 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Infants and young children aged from 3 months to 2 years with acute bronchiolitis.
  2. Infants aged <12 months with respiratory rate over 60 breaths/min, childrens aged >12months with respiratory rate over 50 breaths/min.
  3. Patients with an O2- saturation, breathing room air, under 95%.
  4. Patients with apathy and/or refusal to eat.
  5. Patients with normal white blood cell count for age.
  6. Full term babies without chronic disease.

Exclusion Criteria:

  1. Infants aged < 3 months, children aged >2 years
  2. known or suspected asthma (by observing the good response to first dose of salbutamol nebulization especially among those with personal history of atopy).
  3. Proven or suspected acute bacterial infection.
  4. Presence of symptoms more than 7 days.
  5. Previous treatment with corticosteroid by any route within 2 weeks.
  6. Having a contra- indication to corticosteroid.
  7. Severe cases requiring initial admission to intensive care unit with endotracheal intubation (in order to reduce confounding factors such as nosocomial infection or complication due to mechanical ventilation).
  8. A previous history of intubation.
  9. Premature babies (due to possible respiratory problems associated with prematurity).
  10. Children with chronic cardiopulmonary diseases (Bronchopulmonary- dysplasia , Congenital Heart Disease and Cystic fibrosis)
  11. Children with immunodeficiencies .
  12. Children with neuromuscular disease.

Publications of Results:

Other Publications:
Schimmer BP, Parker KL. Adrenocorticotropic hormone; adrenocortical steroids and their synthetic analogs; inhibitor of the synthesis and actions of adrenocortical hormones. In: Hardman JG, Limbird LE, Molinoff PB, Ruddon RW, Gilman AG,editors. Goodman & Gilman's the pharmacological basis of therapeutics, 9th edition. New York: McGraw-Hill; 1996.pp 1459-1485.
GOODWIN A. An uncontrolled assessment of nebulized budesonide in the treatment of acute bronchiolitis. Br J Clin Res 1995: 6: 113±9.

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Responsible Party: Marina shohdy dous, Principal Investigator., Assiut University Identifier: NCT03436225    
Other Study ID Numbers: Steroid in bronchiolitis.
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marina shohdy dous, Assiut University:
steroid therapy.
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents