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Evaluation of watchful waiting strategy in children with acute otittis media

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200610047724N1
Enrollment
100
Registered
2020-08-11
Start date
2019-03-21
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute otitis media.

Interventions

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 ba

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 15 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahnaz Haghighi

Islamic Azad University

haghighi0005@gmail.com+98 71 3647 2787

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026