Condition 1: Aspiration Pneumonia. Condition 2: Cerebral Palsy. Pneumonitis due to solids and liquids Cerebral palsy
Conditions
Interventions
Intervention 1: In the first phase of the study, patients within the age group of 6 months to 15 years with severe neurological diseases and cerebral palsy who have a history of at least one episode o
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Months to 15 Years
Inclusion criteria
Inclusion criteria: Patients aged between 6 months to 15 years suffering from severe neurological diseases and cerebral palsy undergoing related neurological treatments. Patients who have presented with recurrent respiratory infections and have a previous history of at least one hospitalization due to aspiration pneumonia. Patients who have been evaluated for demographic conditions, socioeconomic level, oral and dental nutrition status, care hygiene, cognitive status, movement and musculoskeletal conditions, and respiratory conditions, including dependence on respiratory devices.
Exclusion criteria
Exclusion criteria: Patients who do not tolerate the oral antibiotic (Amoxicillin) treatment or show gastrointestinal symptoms will be excluded from the study. Any severe illness or medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure in this study is the reduction in the frequency of hospitalizations due to aspiration pneumonia in the children undergoing prophylactic treatment with half-dose amoxicillin, compared to the period when they are not receiving the antibiotic. Timepoint: Baseline measurement: This is done before the intervention starts to document the initial frequency of hospitalizations due to aspiration pneumonia.During the intervention phase (first three months): The primary outcome is measured monthly, providing three data points at the end of the 1st, 2nd, and 3rd month after the start of the intervention.Post-intervention phase (following three months): The frequency of hospitalizations due to aspiration pneumonia is monitored for another three months after discontinuation of the intervention. This gives three additional data points, measured at the end of the 4th, 5th, and 6th month from the start of the study. Method of measurement: Review of Medical Records: The number of hospitalizations each participant has had due to aspiration pneumonia is obtained by reviewing their medical records. This will be done by authorized research personnel who have been trained to accurately extract this information. This method allows for the collection of reliable and accurate data regarding the primary outcome.Patient and Caregiver Reports: In addition to the review of medical records, the caregivers of the patients (or the patients themselves, if appropriate) will be asked about any hospitalizations that have occurred due to aspiration pneumonia. This helps to ensure that all relevant information is captured, even if it might not be reflected in the medical records. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNazanin Nasri
Tehran University of Medical Sciences
Outcome results
None listed