Ethical issues, study design, and patient collection
upper respiratory infections, anxiety, ICH, psychiatric, NCT05378022, depression
DISORDERS, FLU, UPPER RESPIRATORY INFECTIONS, DRUG ALLERGIES
This study received ethics approval by the Ethics Committee in Medical Research of the Vietnam National Children’s Hospital under Decision No. 441/BVNTW-VNCSKTE, and was conducted with the ethical principles in accordance with the Helsinki statement and the ICH GCP guidelines, the Health Department's current ethical regulations and standards of research using subject’s human. All parents of pediatric patients who volunteered to participate in the study were given information about the study and signed an informed consent form. The study was registered with ClinicalTrials.gov of US. National Library of Medicine with Identifier No: NCT05378022 on 17/05/2022.This was a double-blind, randomized, controlled intervention pilot study. Patients were randomly assigned to either the control group (named “Control” group) received 0.9% NaCl or the experimental group (named “Navax” group) received the probiotics LiveSpo Navax. The study was implemented at the International Center, Vietnam National Children’s Hospital from December 2020 to April 2022. The size of the patient cohorts (The inclusion criteria for this study included children of both genders, aged between 4 months and 7 years, who were admitted to the hospital due to upper respiratory infections and tested positive for both flu A and flu B through rapid testing and had consents from parents. Exclusion criteria included newborn babies, having a history of drug allergies, the need for oxygen therapy, being discharged before day 2, being lost to follow-up, being withdrawn from the trial, continuing in the trial but missing data, receiving flu vaccination within one year, and meeting the criteria for psychiatric disorders other than depression and/or anxiety.