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

January 8, 2019 updated by: Marina shohdy dous, Assiut University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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 Names:
  • Fortecortin 8 mg /2 ml ampoule i.v /i.m injection .
Other: 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 Names:
  • Pulmicorte respules1 mg /2 ml.
Other: 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 Names:
  • Farcoline respirator 0,5% solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
<7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of mean duration of symptoms.
Time Frame: <7 days
Improvement of respiratory symptoms within fewer days .
<7 days
Reduction of duration of oxygen therapy.
Time Frame: <7 days
Reduction the need for more oxygen therapy .
<7 days
Reduction of average Length of hospital stay.
Time Frame: <7 days
Decrease Length of hospital stay.
<7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Steroid in bronchiolitis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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