Objectives: Evaluation of the effect of intramuscular injection of a single dose of dexamethasone in infants under 2 years suffering acute bronchiolitis, Design: Study is a randomized double blind clinical trial, Setting and conduct: 80 Infant children under 2 years of age are admitted to the hospital Mohammad Kermanshahi and acute bronchiolitis by specialist physicians diagnosed. If no exclusion criteria were randomly divided into 2 groups, drug and placebo. Participants: Infants less than 2 years old؛ The first episode of wheezing with respiratory distress observed, Upper respiratory tract have infection, ) Intervention: In the drug group (1 mg / kg) intramuscular dexamethasone and placebo groups are equally placebo injection, main outcome measures: RDAI scored arrival time, 4 hours and 7 days after injection in both groups are measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120218974N2
Registration date:2015-03-02, 1393/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-02, 1393/12/11
Registrant information
Name
Simin Gheini
Name of organization / entity
Kermanshah University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3721 8202
Email address
s.gheini@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Siences, Adress: Vice chancellor for research, Building No. 2 of Kermanshah University of Medical Sciences, Shahidbeheshti Bolvar, Kermanshah.
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intramuscular injection of a single dose of dexamethasone in infants under 2 years suffering acute bronchiolitis
Public title
The effect of dexamethasone injection in infants with acute bronchiolitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Infants less than 2 years old؛ The first episode of wheezing with respiratory distress observed؛ Upper respiratory tract have infection. Exclusion criteria: Infants who have a history of wheezing or bronchodilator therapy؛ Prematurity؛ Neonatal ventilation؛ disease of chronic Heart and lung؛ Aspiration؛ Problems nerve / muscle؛ immunocompromised؛ Tachycardia greater than 180 beats per minute؛ respiratory rate of 100 per minute or previous use of glucocorticoid.
Age
From 1 day old to 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Ethics Committee
Street address
Kermanshah University of Medical Sciences; Shahid Beheshti Bolvar; Kermanshah
City
Kermanshah
Postal code
Approval date
2014-01-14, 1392/10/24
Ethics committee reference number
51694
Health conditions studied
1
Description of health condition studied
Acute bronchiolitis
ICD-10 code
J20.9
ICD-10 code description
Acute bronchitis, unspecified
Primary outcomes
1
Description
RADI Score
Timepoint
Arrival time, After 4 hours and 7 day later
Method of measurement
According to the criteria of Respiratory Disease Assessment Instrument
Secondary outcomes
empty
Intervention groups
1
Description
Dexamethasone intramuscularly amount (1 mg / kg body weight)
Category
Placebo
2
Description
placebo intramuscularly amount (1 mg / kg body weight)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Sareh Farshadfar
Street address
Infant Group, Mohammad Kermanshahi Hospital, HelalAhmar Avenue, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research, Building No. 2 of Kermanshah University of Medical Sciences, Shahidbeheshti Bolvar
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Reza Akramipour
Position
Chief of Department of Pediatrics
Other areas of specialty/work
Street address
Department of Pediatrics, Mohammad Kemanshahi Hospital, Helal Ahmar Ave, Kermanshah.
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
Akramipur20@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Simin Gheini
Position
Phd
Other areas of specialty/work
Street address
Department of Pediatrics, Mohammad Kemanshahi Hospital, Helal Ahmar Ave, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
SiminGheini@yahoo.com,
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sareh Farshadfar
Position
Rezident of Pediatric
Other areas of specialty/work
Street address
Department of Pediatrics, Mohammad Kemanshahi Hospital, Helal Ahmar Ave, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
drsfarshadfar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)