Protocol summary

Summary
Acute bronchiolitis is the most common reason for hospitalization of infants during winter. A hypothesis for the effectiveness of epinephrine may be that it exerted an effect on overall infant respiratory mechanics by reducing nasal edema. We studied the effect of drop epinephrine (as a decongestant) with drop Nacl0.9% (as a placebo) on 100 patients between 1 to 12 months with the episode of wheezing, diagnosed as bronchiolitis who need to O2 therapy and admission in hospital. Before treatment the clinical condition (O2 saturation, respiratory rate, heart rate, retraction, dyspenea and wheeze) was evaluated. The first group (A) received routine treatment of bronchiolitis (O2 therapy, salbutamol spray and neubulizer) and also recieved drop phenyephrin 0.5% in supine position that remained in this position for 1 min. The second group (B) received routine treatment of bronchiolitis (O2 therapy, salbutamol spray and neubulizer) and also recieved drop NaCl 0.9% in supine position that remained in this position for 1 min. This is a double blind study. Both drops were colorless and smell less and labile as A and B. Thirty minutes after administration of drug and placebo, O2 saturation, respiratory rate, heart rate, retraction, dyspenea and wheeze were evaluated and scored.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108187371N1
Registration date: 2011-09-29, 1390/07/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-29, 1390/07/07
Registrant information
Name
Marzieh Akbarpour
Name of organization / entity
Zahedan university of medical sceinces
Country
Iran (Islamic Republic of)
Phone
+98 911 135 0386
Email address
akbarpoorm@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison safety and efficacy of Phnylephrine with placebo in treatment of hospitalized children with bronchiolitis
Public title
New regimen of therapy in the treatment of Bronchiolitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ages 4 weeks to 12 months; clinical diagnosis of viral bronchiolitis as the primary reason for hospitalization; presence of an oxygen requirement and a minimum severity score of 1. Exclusion criteria: history of chronic neurologic, heart, kidney, or lung disease; history of prematurity <34 weeks gestation; severity score of >10; use of nebulized albuterol or nebulized epinephrine within 4 hours of study enrollment; use of nasal phenylephrine or oxymetazoline within 12 hours of study enrollment; or “unstable” vital signs. “Unstable” vital signs are defined as heart rate >200 beats/min, blood pressure 2 standard deviations above or below the age appropriate mean, and respiratory rate above 80 breaths/min. The choice of maximum score is somewhat arbitrary but would exclude patients with all of the following: respiratory rate ≥70 breaths/min; intercostal, substernal and supraclavicular retractions; no feeding; and inspiratory and expiratory wheezing or diminished breath sounds.
Age
To 1 year old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
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
The ethics committee of Zahedan University of Medical Sceinces
Street address
Pardis of Zahedan university of medical sciences, Janat bloulovard
City
Zahedan
Postal code
2564-89
Approval date
2010-11-28, 1389/09/07
Ethics committee reference number
89-2564

Health conditions studied

1

Description of health condition studied
bronchiolitis
ICD-10 code
J20
ICD-10 code description
acute bronchiolitis

Primary outcomes

1

Description
respiratory distress
Timepoint
30 minutes after completion of therapy
Method of measurement
physical examination

Secondary outcomes

1

Description
Pulse rate
Timepoint
30 minutes after completion of therapy
Method of measurement
physical examination

2

Description
O2 saturation
Timepoint
30 minutes after completion of therapy
Method of measurement
physical examination

3

Description
dyspenea
Timepoint
30 minutes after completion of therapy
Method of measurement
physical examination

4

Description
retraction
Timepoint
30 minutes after completion of therapy
Method of measurement
physical examination

Intervention groups

1

Description
First group (A) received routine treatment of bronchiolitis and also received a drop phenyephrin 0.5% in supine position that remained in this position for 1 min.
Category
Treatment - Drugs

2

Description
The second group (B) received routine treatment of bronchiolitis and also recieved drop NaCl 0.9% in supine position that remained in this position for 1 min. Thirty minutes after administration of drug and placebo, O2 saturation, respiratory rate, heart rate, retraction, dyspenea and wheeze were evaluated and scored.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of pediatrics Infectious Diseases, Ali ebne Abitaleb Hospital
Full name of responsible person
Marzieh Akbarpour
Street address
Department of pediatrics Infectious Diseases, Ali ebne Abitaleb Hospital, Khalije Fars High way
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellory for Research, Zahedan University of Medical Sceiences
Full name of responsible person
Hamidreza Mahmoudzadeh_Sagheb
Street address
Daneshjo street, Zahedan University of Medical Sceiences
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellory for Research, Zahedan University of Medical Sceiences
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
Zahedan University of Medical Sciences
Full name of responsible person
Marzieh Akbarpour
Position
Resident of pediatrics disease
Other areas of specialty/work
Street address
Department of pediatrics Infectious Disease, Ali ebne Abitaleb Hospital, Khalije Fars High way
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
akbarpoorm@zaums.ac.ir , Pardis_10107@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gholamreza Soleimani
Position
Assistant Professor of pediatrics infectious disease & head of the Department of pediatrics Disease
Other areas of specialty/work
Street address
Ali ebne Abiteleb Hospital, Zahedan University of Medical Sciences, Khalije Fars High way
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
soleimanigh@zaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Marzieh Akbarpour
Position
Resident of pediatrics disease
Other areas of specialty/work
Street address
Department of pediatrics Infectious Diseases, Ali ebne Abitaleb Hospital, Zahedan University of Medical Sciences, Khalije Fars High way
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
akbarpoorm@zaums.ac.ir , Pardis_10107@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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