]>
IRCT20221126056619N1 IRCT 2023-06-11 Tehran University of Medical Sciences investigation the effective of oral amoxicillin with half the therapeutic dose in reducing the hospitalization rate of patients with neuromuscular disease and cerebral palsy due to aspiration pneumonia during the years 1401-1402 Efficacy of Half-Dose Oral Amoxicillin in Reducing Hospitalization Rates for Aspiration Pneumonia in Patients with Neuromuscular Disease and Cerebral Palsy: A Randomized Controlled Trial 2023-06-22 anticipated 60 Complete https://irct.ir/trial/70582 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: a suitable randomization method could be block randomization, which would ensure equal numbers of participants receive either half-dose amoxicillin or a placebo, at any given time. Individual participants would be the unit of randomization, and if necessary, stratified randomization could be used to control for variables like age, disease severity, or sex. A computerized random number generator, in software like Microsoft Excel or SPSS, would be used to create the random allocation sequence. The random sequence, built based on the chosen randomization method, would be used to assign participants to groups in a way that conceals allocation. This could be accomplished using a centralized web-based system which reveals the participant's group only after enrollment is confirmed, hence preventing selection bias. This randomization strategy, if implemented, would convert your study into a randomized controlled trial, enabling direct comparison of the effectiveness of prophylactic half-dose amoxicillin versus a placebo in preventing aspiration pneumonia in your target population, Blinding description: blinding applied to three groups: the participants, the individuals administering the interventions, and the team evaluating the outcomes. Let's go through how this can be achieved for each group: Participants: the patients (or their caregivers) will not be told whether they are receiving the amoxicillin or the placebo. Both the amoxicillin and the placebo will need to look and taste identical, to prevent the participants from guessing their group assignment. Healthcare Providers: Physicians, nurses, physiotherapists, and any other professionals involved in administering the intervention or providing care to participants during the trial will also be blinded. They won't know whether they're administering amoxicillin or placebo to a particular patient. This could be achieved by having a separate team responsible for the packaging and labeling of the intervention (amoxicillin or placebo). The intervention would be delivered in an identical, coded package, and the code would only be broken once the study is completed. Outcome Assessors and Data Collectors: Those who assess the outcomes (for example, frequency of aspiration pneumonia) and those who collect the data will also be blinded to group assignment. They'll only have access to the coded group assignments and won't know which code corresponds to the amoxicillin group and which corresponds to the placebo group. This is important to ensure that their knowledge doesn't influence the assessment of outcomes or data collection. N/A Condition 1: Aspiration Pneumonia. Condition 2: Cerebral Palsy. 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 of hospitalization due to aspiration pneumonia are administered half-dose Amoxicillin (25 mg per kg of body weight) orally, on a daily basis, for three months, in addition to their standard neurological treatment. Intervention 2: Control group: In the second phase of the study, the same group of patients as in Intervention Group 1 discontinue the use of Amoxicillin for the following three months while continuing with their standard neurological treatment. The outcome (number of hospitalizations due to aspiration pneumonia) during this phase without antibiotic treatment serves as the control for comparison. Yes - There is a plan to make this available What will be shared: This dataset will include all collected de-identified Individual Participant Data (IPD) pertaining to this study. This includes: Baseline demographic information (age, gender, neurological condition specifics, past medical history) Detailed dosage and duration information related to the administration of Amoxicillin. Information regarding standard neurological treatments given alongside the study intervention. Outcome data concerning frequency of hospitalizations due to aspiration pneumonia during both the intervention phase and control phase. Any recorded side effects or adverse events. Please note that all data will be fully anonymized to protect participant privacy, and any sensitive data fields will be carefully managed in compliance with relevant data protection regulations. When: The data from this clinical trial will become available starting six months after the publication of the study's primary results, anticipated to be around January 2024. These files will remain accessible for a period of five years until December 2028. This window of availability allows for further independent analysis and meta-analysis by interested researchers while maintaining the balance with the need for data freshness and relevancy. Access requests submitted after the end date will be reviewed on a case-by-case basis. To whom: The de-identified individual participant data (IPD) and supporting documents will be shared with qualified researchers worldwide, regardless of their affiliation with academic, non-profit, or for-profit organizations. The primary requirement is that the requesting party must be engaged in health-related research and have a methodologically sound proposal for the use of data. Requests from all eligible parties will be considered to promote widespread data utilization and advance our collective understanding of severe neurological disorders and aspiration pneumonia in children. Conditions: Access to the de-identified individual participant data (IPD) and associated documents will be granted for purposes of scientific research that aligns with public good. Requests for access will be reviewed based on the following criteria: The proposed study must have a clear scientific aim and a sound methodology. The requested data must be necessary to achieve this aim. The requesting researcher or research team must demonstrate adequate expertise and experience to conduct the proposed analysis. The proposed use of data must comply with relevant ethical standards and regulations for data protection and patient privacy. The requester must commit to use the data only for the proposed analysis, to not attempt to identify individual participants, and to securely destroy the data after the completion of the analysis. Requests for data access will be reviewed by a data access committee, composed of members of our research team and independent experts. The committee will assess each request based on the outlined criteria and provide a response within four weeks of the request. If access is granted, data will be shared through a secure data-sharing platform, along with relevant documentation to aid in its interpretation and use. Where to obtain: All requests for the de-identified individual participant data (IPD) and accompanying documents should be directed to the study's principal investigator. Interested researchers can submit a written proposal detailing their intended use of the data to the following email address: [sh.mirlohi۲۰۰۴@gmail.com]. Please note that all requests will be acknowledged upon receipt, and you will be updated regarding the status of your request within four weeks. How to obtain: The process to access these documents or data files is designed to ensure a secure, ethical, and effective use of the data. The steps involved are as follows: Initial Proposal Submission: Interested researchers should first submit a written proposal to the specified email address. This proposal should outline the purpose of the requested data, the specific datasets required, and the proposed statistical analysis method. Proposal Review: Upon receiving a proposal, our research team will review it to ensure that the requested data will be used for valid scientific or medical research. This review process usually takes about 2-4 weeks. Data Use Agreement: If the proposal is approved, the researcher will be asked to sign a data use agreement. This agreement outlines the terms and conditions for using the data, including commitments to maintain participant confidentiality, not to attempt re-identification, to use the data only for the approved purpose, and to dispose of the data after the agreed period. Data Access: Once the data use agreement is signed and returned, our data management team will prepare the requested datasets. This process may take another 2-4 weeks, depending on the complexity and size of the requested data. Follow-Up: After the data is received, the researchers are expected to comply with periodic progress reports and to share their findings with our team before any publication or public dissemination of results. In total, researchers should anticipate that the entire process, from initial proposal submission to receiving the data, may take up to 2-3 months. We encourage researchers to plan accordingly and appreciate their understanding and patience. Comments:
public Nazanin Nasri
No 7,center ordibehesht,south makooyi poor,behzadi blvd,zaferaniyeh neighbourhood
Tehran Iran (Islamic Republic of) 1419733151 +98 21 2240 9720 nasri_nazanin@yahoo.com Tehran University of Medical Sciences scientific Nazanin Nasri
No 7,center ordibehesht,south makooyi poor,behzadi blvd,zaferaniyeh neighbourhood
Tehran Iran (Islamic Republic of) 1419733151 +98 21 2240 9720 nasri_nazanin@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 6 months 15 years Both 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. J69 G80 Pneumonitis due to solids and liquids Cerebral palsy Prevention Prevention 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 of hospitalization due to aspiration pneumonia are administered half-dose Amoxicillin (25 mg per kg of body weight) orally, on a daily basis, for three months, in addition to their standard neurological treatment. Control group: In the second phase of the study, the same group of patients as in Intervention Group 1 discontinue the use of Amoxicillin for the following three months while continuing with their standard neurological treatment. The outcome (number of hospitalizations due to aspiration pneumonia) during this phase without antibiotic treatment serves as the control for comparison. 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. Tehran University of Medical Sciences Approved 2023-06-06 Ethics committee of Tehran University of Medical Sciences Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran tehran Tehran Iran (Islamic Republic of)