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Determining the effect of vitamin A on persistent wheezing of infants with bronchiolitis admitted to Ali ibn Abi Talib hospital of Zahedan

Protocol summary

Study aim
Determining the Effect of Vitamin A on persistent wheezing of Infants with bronchiolitis admitted to Ali ibn Abi Talib hospital of Zahedan
Design
A randomized, without blindness, sham-controlled clinical trial with a parallel group postoperative care and outcome assessment, design of 60 patients, enrolled between March 2018 and March 2019 and followed for one year
Settings and conduct
This study will be performed in Imam Ali Hospital in Zahedan. 60 infants aged 1 month to 2 years are included in the study after confirming of bronchiolitis by a specialist and no history of previous disease. Patients will be divided into two groups of case and control with random blocks. Then, the patient's demographic information and severity of symptoms will be recorded. For both groups, the usual treatment of bronchiolitis and for the case group also 5,000 units per kg of body weight of the injected vitamin A will be prescribed. Then, all patients will be visited regarding severity of symptoms by one assisted pediatrician, 24 hours after injection (during hospitalization), at the time of discharge, and 2 weeks after that.
Participants/Inclusion and exclusion criteria
After getting history and performing a physical examination, Infants with bronchiolitis from one month to two years were included to the study and patients with a history of congenital heart disease, pulmonary, asthma or other immunodeficiencies and other chronic diseases, also if the diagnose changed during this study, were excluded.
Intervention groups
The intervention group consists of 30 infants who receive the usual treatment of Bronchiolitis, such as Cold Oxygen Steam and Bronchodilator and 5,000 units per kg body weight of injected vitamin A.
Main outcome variables
severity of wheezing, retraction status, respiratory rate, and general condition of the patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180425039418N5
Registration date: 2019-03-04, 1397/12/13
Registration timing: registered_while_recruiting

Last update: 2019-03-04, 1397/12/13
Update count: 0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
mohammad Ghena'at Pisheh Sanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 1227
Email address
mohammad.ghenaat71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of vitamin A on persistent wheezing of infants with bronchiolitis admitted to Ali ibn Abi Talib hospital of Zahedan
Public title
vitamin A effect on post bronchiolitis wheezing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with a history of upper respiratory tract infection (runny nose - cough) with increased respiratory effort and abnormal auditory findings. Acquiring informed consent of parents Being Term at birth Normal weight at birth and during admission Not having chronic or congenital lung, cardiac, neurological diseases and immune deficiency No vitamin A intake before entering to the study
Exclusion criteria:
Other diagnoses for the patients during admission Parental dissatisfaction to continue participating in the study
Age
From 1 month old to 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The random blocks method was used (based on the preliminary estimate of the number of clients in December 2016 and the first 3 months of 2018)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Campus of Medical Scineces, Dr.Hesabi Squar
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-03-20, 1396/12/29
Ethics committee reference number
IR.ZAUMS.REC.1396.14

Health conditions studied

1

Description of health condition studied
Bronchiolitis
ICD-10 code
J21.9
ICD-10 code description
Acute bronchiolitis, unspecified

2

Description of health condition studied
Post Bronchiolitis Wheezing
ICD-10 code
R06.2
ICD-10 code description
Wheezing

Primary outcomes

1

Description
Severity of wheezing in bronchiolitis
Timepoint
At 24 hours after the injection (during the patient's hospitalization), during discharge and two weeks after discharge
Method of measurement
Littmann Stethoscope 3M

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" Includes 30 infants from one month to two years old with the first episode of Bronchiolitis referring to Ali ibn Abi Talib Hospital in Zahedan, prescribed with 5,000 units per kilogram body weight of injected vitamin A.
Category
Treatment - Drugs

2

Description
Control group: No additional work
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali-ibn-Abitaleb Hospital
Full name of responsible person
Gholamreza Soleimani
Street address
Salamat Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
it@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Ansari Moghaddam
Street address
Dr.Hesabi Square, Campus of Medical Scineces
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Afsaneh Mirshekari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Campus of Medical Scineces, Dr.Hesabi Squar
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
mohammad.ghenaat71@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Afsaneh Mirshekari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Campus of Medical Scineces, Dr.Hesabi Squar
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
Afsanemir4@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Afsaneh Mirshekari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Campus of Medical Scineces, Dr.Hesabi Squar
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
mohammad.ghenaat71@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no information yet
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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