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Evaluation of watchful waiting strategy in the treatment of acute otitis media in children 6 month to 18 years of age

Protocol summary

Study aim
The aim of this study is to evaluate watchful waiting strategy in acute otitis media in children 6 month to 18 years of age.
Design
sampling method was simple and referral base. Information was recorded. Follow-up steps were directly taken by the doctor using examination and telephone conversation. For waiting groups, they were warned that no antibiotics should be given to the child. In case of persistence or worsening the symptoms, they should be referred within 48-72 hours after the onset of rapid symptoms for reassessment and the initiation of antibiotics. Alternatively, in case of no referral or contact with the researcher, the researcher asked the child's situation by telephone with the parents.
Settings and conduct
non-randomized clinical trial in Shiraz ,Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:children aged between 6 months and 18 years, the presence of mild to moderate AOM, fever less than 39 ° C. Exclusion criteria include recent antibiotic use, facial or cranial deformities, immunodeficiency, malnutrition, frequent history of AOM, history of hearing problems, tympanic membrane perforation, Down syndrome, severe AOM, otorrhea, and poor compliance.
Intervention groups
Watchful waiting group .All of children put on(Watchful waiting) are monitored for up to 72 hours if there was no proper response take antibiotics if needed. Then compare children who recover without antibiotics with those we have to use.
Main outcome variables
Improving the clinical symptoms (descriptive and examination) including pain and fever and relieving inflammation of the eardrum

General information

Reason for update
Acronym
child otitis media study(COMS)
IRCT registration information
IRCT registration number: IRCT20200610047724N1
Registration date: 2020-08-11, 1399/05/21
Registration timing: retrospective

Last update: 2020-08-11, 1399/05/21
Update count: 0
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
Mahnaz Haghighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 2787
Email address
haghighi0005@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-02-20, 1398/12/01
Scientific title
Evaluation of watchful waiting strategy in the treatment of acute otitis media in children 6 month to 18 years of age
Public title
Evaluation of watchful waiting strategy in children with acute otittis media
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children aged between 6 months and 18 years, the presence of mild to moderate AOM, fever less than 39 ° C,no toxicity or pussy discharge from the ears physical exam suggestive for AOM ( acute otitis media)
Exclusion criteria:
recent antibiotic use facial or cranial deformities immunodeficiency, malnutrition,HIV history of hearing problems, tympanic membrane perforation frequent history of AOM Down syndrome poor compliance
Age
From 6 months old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The watchful waiting intervention in our study is non-pharmacological. Patients do not have a control group. All patients put on watchful waiting strategy at first except in critical cases. Within 72 hours, those patients who do not respond properly will receive antibiotics.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic commitee of Islamic Azad University Kazeroon Branch
Street address
Shiraz,No.4,Mollasadra Street,Mollasadra medical center,3Floor
City
Shiraz
Province
Fars
Postal code
7193615411
Approval date
2020-06-11, 1399/03/22
Ethics committee reference number
IR.IAU.KAU.REC.1399.014

Health conditions studied

1

Description of health condition studied
Acute otitis media
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percentage of children recovering without antibiotics
Timepoint
72 hours , a week and two weeks after treatment
Method of measurement
Improving the patient's symptoms, including fever and autoscopic ear examinations

Secondary outcomes

1

Description
Clinical improvement, elimination of ear pain, restlessness, anorexia, general well-being and elimination of inflammation of the eardrum in the examination
Timepoint
First visit ,48 to 72 hours later, One to two weeks after the first visit
Method of measurement
Ear examination and current present illness

Intervention groups

1

Description
All patients enrolled to the study with a diagnosis of middle ear infection, if they do not meet the conditions for immediate and emergency antibiotic administration, the treatment decision will be based on watchful waiting ,that means the child will be monitored up to 72 hours without antibiotics prescription (only simple analgesics such as acetaminophen if necessary). Antibiotics are prescribed if warning signs such as worsening of the patient's general symptoms, uncontrollable fever, vomiting, lethargy and intolerance to food are detected within 72 hours. During this period, we monitor the child's symptoms through face-to-face or telephone examination and observation of symptoms and signs .The group has been treated without treatment only under supervision will be the watchful waiting group and those who have not responded in this way and we have to prescribe antibiotics will be in the antibiotic group.Then both groups will be compare in terms of different variables such as sex ,age, post nasal discharge ,adenoid hypertrophy unilateral or bilateral ears involvement and history of atopic conditions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Dr Mahnaz Haghighi
Street address
No4.allay ,Mollasadra street ,Mulla Sadra Medical Building, third floor
City
Shiraz
Province
Fars
Postal code
71936-15411
Phone
+98 71 3647 2787
Email
haghighi0005@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mohammad Hosain Marhamatizade
Street address
5 km of Kazerun-Bushehr road, mailbox168/73135
City
Kazeroon
Province
Fars
Postal code
7319846451
Phone
+98 71 4223 9933
Fax
+98 71 4223 0508
Email
drmarhamati@gmail.com
Web page address
https://www.kau.ac.ir/%D9%85%D8%AF%DB%8C%D8%B1%DB%8C%D8%AA/%D8%AD%D9%88%D8%B2%D9%87-%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D9%BE%DA%98%D9%88%D9%87%D8%B4%DB%8C/%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA-%D9%BE%DA%98%D9%88%D9%87%D8%B4%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Mahnaz Haghighi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.4 , Mollasadra street , Mollasadra medical center , 3Floor
City
Shiraz
Province
Fars
Postal code
کدپستی۱۵۴۱۱-۷۱۹۳۶
Phone
+98 71 3647 2787
Fax
Email
haghighi0005@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Haghighi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.4 , Mollasadra street , Mollasadra medical center , 3Floor
City
Shiraz
Province
Fars
Postal code
کدپستی۱۵۴۱۱-۷۱۹۳۶
Phone
+98 71 3647 2787
Fax
Email
haghighi0005@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Haghighi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.4 , Mollasadra street , Mollasadra medical center , 3Floor
City
Shiraz
Province
Fars
Postal code
کدپستی۱۵۴۱۱-۷۱۹۳۶
Phone
+98 71 3647 2787
Fax
Email
haghighi0005@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic Information of Patients, Clinical Symptoms and signs, therapeutic approach including Watchful and waiting versus antibiotic therapy will be available
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
All academic and non-academic researchers
Under which criteria data/document could be used
In order to design and perform similar interventions at a larger size, access to data and applied analysis is possible.
From where data/document is obtainable
Personal email, mobile number and work phone number of researcher.
What processes are involved for a request to access data/document
Documents will be sent within 4 to 8 weeks after the application
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