Adjuvant Therapy for Improved Acute Otitis Media Outcomes in Infants
Antihistamine
+ Corticosteroid
Ear Diseases+1
+ Otitis
+ Otorhinolaryngologic Diseases
Treatment Study
Summary
Acute otitis media, a common childhood disease, often leads to hearing loss in children. Despite the existence of effective antibiotics, treatment failures, persistent fluid buildup, and recurrences are common. This study focuses on infants under one year old, aiming to improve their acute and long-term outcomes. The research explores if adding adjuvant therapy, either an antihistamine or a corticosteroid, to antibiotic treatment can enhance recovery. This could potentially address current challenges in treatment, providing a more effective solution for this condition. During this Phase III study, participants receive both antibiotic therapy and either an antihistamine or a corticosteroid. The study lasts for one year after enrollment. The impact of this combined treatment approach is evaluated to determine if it reduces treatment failures, persistent fluid buildup, and recurrences. By testing this new approach, the study hopes to find a more reliable treatment for acute otitis media in infants.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 Months to 1 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Univ of Texas Med Branch Children's Hosp
Galveston, United StatesOpen Univ of Texas Med Branch Children's Hosp in Google Maps