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

Primary Purpose

Bronchiolitis; Respiratory Syncytial Virus

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Dexamethasone orally.
Dexamethasone parenteral.
Inhaled nebulized Budesonide.
Inhaled nebulized salbutamol.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis; Respiratory Syncytial Virus focused on measuring steroid therapy.

Eligibility Criteria

3 Months - 2 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Group one

    Group two

    Group three

    Group four

    Arm Description

    Group one will receive dexamethasone orally (0.15mg /kg / dose) twice daily for 3 to 5 days.

    Group two will receive dexamethasone parenteral (0.15mg /kg /dose) twice daily for 3 to 5 days.

    Group three will receive inhaled nebulized budesonide (1 mg/2ml) twice daily for 3 to 5 days.

    Group four will receive symptomatic treatment in form of inhaled nebulized salbutamol(0.15mg/kg/ dose) daily every 6-8 hours.

    Outcomes

    Primary Outcome Measures

    Resolution of respiratory distress.
    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

    Reduction of mean duration of symptoms.
    Improvement of respiratory symptoms within fewer days .
    Reduction of duration of oxygen therapy.
    Reduction the need for more oxygen therapy .
    Reduction of average Length of hospital stay.
    Decrease Length of hospital stay.

    Full Information

    First Posted
    February 12, 2018
    Last Updated
    January 8, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03436225
    Brief Title
    Steroid Therapy in Acute Bronchiolitis A New Old Line of Therapy.
    Official Title
    Steroid Therapy in Acute Bronchiolitis A New Old Line of Therapy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    February 2019 (Anticipated)
    Study Completion Date
    March 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Bronchiolitis is an acute lower respiratory tract infection in early childhood.A subcommittee of the American Academy of Pediatrics (AAP) together with the European Respiratory Society (ERS) underlined that is a clinical diagnosis, recognized as "a constellation of clinical symptoms and signs including a viral upper respiratory prodrome followed by increased respiratory effort and wheezing in children less than 2 years of age". Bronchiolitis is the common reason for hospitalization of children in many countries, challenging both economy, area and staffing in pediatric departments. A substantial proportion of children will experience at least one episode with bronchiolitis, and as much as 2-3% of all children will be hospitalized with bronchiolitis during their first year of life. Bronchiolitis is the most common medical reason for admission of children to intensive care units (ICU) particularly those with risk Factors will have a severe course of bronchiolitis, providing challenges regarding ventilation, fluid balance and general support This may be a particular challenge for ICUs without a specialized pediatric section. Many respiratory viruses have been associated with acute viral bronchiolitis although Respiratory Syncytial Virus (RSV) remains the most common identified virus causing bronchiolitis, occurring in epidemics during winter months.The infection starts in the upper respiratory tract, spreading to the lower airways within few days.The inflammation in the bronchioles is characterized by a peri-bronchial infiltration of white blood cell types, mostly mono nuclear cells, and oedema of the submucosa and adventitia. Damage may occur by a direct viral injury to the respiratory airway epithelium, or indirectly by activating immune responses. Oedema, mucus secretion, and damage of airway epithelium with necrosis may cause partial or total airflow obstruction, distal air trapping, atelectasis and a ventilation perfusion mismatch leading to hypoxemia and increased work of breathing. Smooth-muscle constriction seems to play a minor role in the pathologic process of bronchiolitis. Risk factors for bronchiolitis are male gender, a history of prematurity, young age, being born in relation to the RSV season, pre-existing disease such as broncho pulmonary- dysplasia , underlying chronic lung disease , neuromuscular disease, congenital heart- disease , exposure to environmental tobacco smoke , high parity, young maternal age, short duration/no breast feeding , maternal asthma and poor socioeconomic factors. Bronchiolitis often starts with rhinorrhoea and fever, thereafter gradually increasing with signs of a lower respiratory tract infection including tachypnoea, wheezing and cough. Very young children, particularly those with a history of prematurity, may appear with apnea as their major symptom.Feeding problems are common. On clinical examination, the major finding in the youngest children may be fine inspiratory crackles on auscultation, whereas high-pitched expiratory wheeze may be prominent in older children. By observation, the infants may have increased respiratory rate, chest movements, prolonged expiration, recessions, use of accessory muscles, cyanosis and decreased general condition. No routine laboratory or radio graphic diagnostic tests for bronchiolitis except for pulse oxymetry , have been shown to have a substantial impact on the clinical course of bron- chiolitis , and recent guidelines and evidence-based reviews recommend that no diagnostic tests are used routinely. The present study describes the efficacy of steroid therapy in patients with acute bronchiolitis. Theoretically, corticosteroid, an anti-inflammatory agent, should be helpful in the treatment of bronchiolitis because airway inflammation and edema are the main pathophysiologies. Recent evidence has shown elevation of interleukins and other inflammatory mediators in the respiratory tracts of children with acute bronchiolitis. Eosinophil cationic protein, implicated in the pathogenesis of asthma, was found to have a significant role in RSV bronchiolitis. Most of these mediators could be found during the period of virus replication.The clinical effect of dexamethasone, with a long half -life of 36-72 hr, may peak after 3-4 hr of treatment. Corticosteroids widely used in different routes in the treatment of acute bronchiolitis: Dexamethasone injection used in hospitalized children with acute bronchiolitis showed significantly reduction in the mean respiratory distress duration, mean duration of oxygen therapy and the mean length of hospital stay. Oral dexamethasone used in pediatric out patients with acute bronchiolitis produced demonstrable clinical improvement in the initial 4 hr of treatment and reduced the hospitalization rate. Corticosteroid inhalation therapy used in RSV- bronchiolitis showed evidence of prolonged positive effects in reduction of the incidence of subsequent respiratory symptoms in the near future. However, the best and sufficient length of the treatment period, as well as the dose of the inhaled steroid, need to be determined.. Fluticasone propionate, a potent corticosteroid, has been demonstrated in vitro to inhibit virus-induced chemokine production by airway cells in patients infected with Respiratory Syncytial Virus. However, the inhibition was found to take at least 48 hr to reach its full effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis; Respiratory Syncytial Virus
    Keywords
    steroid therapy.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group one
    Arm Type
    Other
    Arm Description
    Group one will receive dexamethasone orally (0.15mg /kg / dose) twice daily for 3 to 5 days.
    Arm Title
    Group two
    Arm Type
    Other
    Arm Description
    Group two will receive dexamethasone parenteral (0.15mg /kg /dose) twice daily for 3 to 5 days.
    Arm Title
    Group three
    Arm Type
    Other
    Arm Description
    Group three will receive inhaled nebulized budesonide (1 mg/2ml) twice daily for 3 to 5 days.
    Arm Title
    Group four
    Arm Type
    Other
    Arm Description
    Group four will receive symptomatic treatment in form of inhaled nebulized salbutamol(0.15mg/kg/ dose) daily every 6-8 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone orally.
    Other Intervention Name(s)
    Apidone syrup., Phenadone syrup.
    Intervention Description
    Administered orally (0.15mg /kg / dose) twice daily for 3 to 5 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone parenteral.
    Other Intervention Name(s)
    Fortecortin 8 mg /2 ml ampoule i.v /i.m injection .
    Intervention Description
    Administered parenteral (0.15mg /kg / dose) twice daily for 3 to 5 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Inhaled nebulized Budesonide.
    Other Intervention Name(s)
    Pulmicorte respules1 mg /2 ml.
    Intervention Description
    Administered for inhalation (1 mg/ 2ml) twice daily for 3 to 5 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Inhaled nebulized salbutamol.
    Other Intervention Name(s)
    Farcoline respirator 0,5% solution.
    Intervention Description
    Administered for inhalation (0.15mg /kg / dose) daily every 6-8hrs
    Primary Outcome Measure Information:
    Title
    Resolution of respiratory distress.
    Description
    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
    Time Frame
    <7 days
    Secondary Outcome Measure Information:
    Title
    Reduction of mean duration of symptoms.
    Description
    Improvement of respiratory symptoms within fewer days .
    Time Frame
    <7 days
    Title
    Reduction of duration of oxygen therapy.
    Description
    Reduction the need for more oxygen therapy .
    Time Frame
    <7 days
    Title
    Reduction of average Length of hospital stay.
    Description
    Decrease Length of hospital stay.
    Time Frame
    <7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infants and young children aged from 3 months to 2 years with acute bronchiolitis. Infants aged <12 months with respiratory rate over 60 breaths/min, childrens aged >12months with respiratory rate over 50 breaths/min. Patients with an O2- saturation, breathing room air, under 95%. Patients with apathy and/or refusal to eat. Patients with normal white blood cell count for age. Full term babies without chronic disease. Exclusion Criteria: Infants aged < 3 months, children aged >2 years known or suspected asthma (by observing the good response to first dose of salbutamol nebulization especially among those with personal history of atopy). Proven or suspected acute bacterial infection. Presence of symptoms more than 7 days. Previous treatment with corticosteroid by any route within 2 weeks. Having a contra- indication to corticosteroid. 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). A previous history of intubation. Premature babies (due to possible respiratory problems associated with prematurity). Children with chronic cardiopulmonary diseases (Bronchopulmonary- dysplasia , Congenital Heart Disease and Cystic fibrosis) Children with immunodeficiencies . Children with neuromuscular disease.

    12. IPD Sharing Statement

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

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