study objective: The role of intranasal corticosteroid treatment on adenoid hypertrophy in children.
inclusion criteria:children between 2-14 with hyper trophic adenoid.Exclusion criteria:corticosteroid therapy more than 1 month;children with anatomical defects in head and neck.
In this clinical trial(before-after) study,between April 2012 and May 2013,45 children between 2 to 14 years old who were affected by adenoid hypertrophy and clinical symptoms(snoring,sleep apnea,...) and had referred to Otorhinolaryngology and Allergy clinics were recruited.the primary outcome was measured with the questionnaires.After doing skin prick test, children were assigned randomly to receive intranasal corticosteroid for 8 weeks.At the end of the 8 week course of treatment,all children were reassessed to evaluate the efficacy of treatment.It is important to mention that the administered medicine was verified with references and is one of the routine treatments in allergic rhinitis,no invasive procedure was done.The process carried out for diagnosis and treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303069429N2
Registration date:2013-09-20, 1392/06/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-20, 1392/06/29
Registrant information
Name
Mahnaz Sadeghi shabesteri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
sadeghim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-11-05, 1390/08/14
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of intranasal corticosteroid in treatment of adenoid hypertrophy in children
Public title
The role of nasal corticosteroid treatment on Adenoid
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:children between 2-14 with hypertrophic adenoid
exclusion:corticostreoid therapy more than 1 month;children with anatomical defects in head and neck
Age
From 2 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Departement of Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Postal code
0098
Approval date
2013-08-22, 1392/05/31
Ethics committee reference number
9280
Health conditions studied
1
Description of health condition studied
هیپرتروفی ادنویید
ICD-10 code
D10
ICD-10 code description
D10.6
Primary outcomes
1
Description
adenoid size
Timepoint
before and after 8 week of corticosteroid therapy
Method of measurement
clinical symptoms such as snoring ...and adenoid size
Secondary outcomes
1
Description
clinical manifestation and neck radiography
Timepoint
before and 8 weeks after corticostreoidtherapy
Method of measurement
questionnaire
Intervention groups
1
Description
intranasal corticosteroid(Fluticasone),100 milligrams at night is administered for all 45 cases and after 8 week course of treatment, symptoms of adenoid hypertrophy will be evaluated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy and ENT clinicas
Full name of responsible person
ENT specialist
Street address
Children Hospital , Sheshgelan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Students Research Comittee of Tabriz University of Medical Sciences
Street address
Medical Faculty
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Medical Faculty
Full name of responsible person
Mahnaz Sadeghi Shabestari
Position
Immunologist Allergist /Associated Professor
Other areas of specialty/work
Street address
Childrens Hospital
City
Tabriz
Postal code
0098
Phone
+98 41152622505
Fax
+98 41 1526 2280
Email
sadeghim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Mahnaz Sadeghi Shabestari
Position
Associated Professor
Other areas of specialty/work
Street address
Childrens Hospital
City
Tabriz
Postal code
0098
Phone
+98 41152622505
Fax
+41 15262280
Email
drsadeghim2004@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Mahnaz Sadeghi Shabestari
Position
Associated Professor
Other areas of specialty/work
Street address
Children Hospital , Sheshgelan
City
Tabriz
Postal code
0098
Phone
+98 41152622505
Fax
+98 41 1526 2280
Email
drsadeghim2004@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)