Determining and comparing the effects of bronchodilators with corticosteroids and bronchodilators in patients referred to bronchiolitis to the specialized clinic of Imam Khomeini Hospital in Ilam in 1300-1499
Design
This study is a double-blind randomized clinical trial in which all infants aged 2 to 24 months with the first Weiss attack who are diagnosed with bronchiolitis need to be hospitalized and receive oxygen and have a minimum score of 4 according to the CBSS criteria table.
30 people in each group, the total volume of 60 people was calculated assuming equality of variance.
Settings and conduct
This study is a clinical trial study in which the study population is all children aged 24-24 months who have referred to the specialized pediatric clinic of Imam Khomeini Hospital in Ilam during the year with a diagnosis of viral bronchiolitis.
Participants/Inclusion and exclusion criteria
This study is a double-blind randomized clinical trial in which all infants aged 2 to 24 months with the first Weiss attack who are diagnosed with bronchiolitis need to be hospitalized and receive oxygen.
Intervention groups
Infants aged 2 to 24 months with a diagnosis of bronchiolitis
Main outcome variables
Oxygen saturation, pulse rate and respiration rate, RDA Score and Clinical Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220225054120N1
Registration date:2022-05-11, 1401/02/21
Registration timing:registered_while_recruiting
Last update:2022-05-11, 1401/02/21
Update count:0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Zahra Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4444 2476
Email address
z.maleki69@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-07, 1401/02/17
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of comparing bronchodilators with corticosteroids and bronchodilators in children with bronchiolitis
Public title
Evaluation of the effect of comparing bronchodilators with corticosteroids and bronchodilators in children with bronchiolitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria Based on the standard definition of bronchiolitis, the first or second episode of respiratory distress with wheezing and clinical evidence of viral respiratory infection such as body temperature 38 ° C and above, tachypnea and tachycardia or Coryza symptoms.
Exclusion criteria:
History of more than two episodes of respiratory distress in the past.
Chronic heart and lung disease
Immunodeficiency
Down Syndrome
Metabolic or neurological illness
History of prematurity (less than 34 weeks of Gesteitional age)
Use of mechanical ventilation in infancy
Positive family history of utopia
Ill child in need of hospitalization due to dehydration, decreased level of consciousness, lethargy or symptoms of respiratory failure
Age
From 2 months old to 24 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, the researcher uses the main entry and exit conditions of the study to prepare a list of eligible patients to participate in this study. If you wish and consent to participate in this research study, general information and written consent. Will be taken from patients' families. Then 60 patients with bronchiolitis are randomly divided into control group or intervention group using block randomization method by hiding random allocation. The control group will receive only the standard treatment protocol, but the intervention group will receive corticosteroids in addition to the standard treatment protocol.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the drug (intervention or comparison group) in sealed packets encoded. The coding is done by one of the project partners and the doctor, the evaluator and the patient are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Ilam, Bangangab, Research Blvd., Ilam University of Medical Sciences,
City
ilam
Province
Ilam
Postal code
٦٩٣٩١٧٧١٤٣
Approval date
2022-01-08, 1400/10/18
Ethics committee reference number
IR.MEDILAM.REC.1400.203
Health conditions studied
1
Description of health condition studied
Bronchiolitis
ICD-10 code
J11.1
ICD-10 code description
Influenza due to unidentified influenza virus with other respiratory manifestations
Primary outcomes
1
Description
All infants 2 to 24 months of age with the first Wise attack who are diagnosed with bronchiolitis need to be hospitalized and receive oxygen
Timepoint
After initial evaluation (on arrival), second evaluation (1 hour appointment) (1 dose of hydrocortisone ampoule, 5 mg per kg body weight and ventolin nebulizer at a dose of 0.15 mg per kg body weight (minimum dose) 2.5 mg and a maximum of 5 mg) and continue ventilation every 20 minutes for up to 3 doses, including monitoring of oxygen prevalence (using pulse oximetry), respiration rate, and pulse rate. In addition to oxygen saturation, Pulse rate and respiration rate, RDA Score and Clinical Score will also be checked and recorded
Method of measurement
CBSS table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group: hydrocortisone with Oxycort brand 5 mg per weight (one dose) and bronchodilator as ventolin or salbutamol at a dose of 0.15 mg per weight with an interval of 20 minutes, up to one hour in three times. / The second group only bronchodilator In the form of ventolin or salbutamol at a dose of 0.15 mg per weight at intervals of 20 minutes, up to one hour in three doses