* If you want to update the article please login/register
Participants in the study's setting: Patients requiring hospitalization in 4 paediatric departments or education in the emergency department will be recruited from patients requiring hospitalization in 4 paediatric departments or consulting in the emergency department due to AGE in the Paediatric Teaching Clinical Hospital, the Medical University of Warsaw, will be recruited from patients requiring hospitalization. If there is an indication for a microbiological stool testing, the stool sample will be cultured. The Bristol Stool Form Scale will help with stool consistency testing. Randomization: The randomization will involve the random assignement of patients to group A or B. The number of bottles in the box will be randomly assigned to the next four patients in a subgroup by the researcher by opening each subsequent box. Intervention: Patients in the experimental group will receive Imunoglukan PH4 oral suspension in a dose 1 ml / 5 kg body weight, while those in the control group will receive a placebo: a vitamin C oral suspension in a dose 1 ml / 5 kg body weight. According to the ESPGHAN guidelines, patients will be tested every day by the physician, with the determination of dehydration level, the need for intravenous rehydration, or concomitant therapy. Both during and after the hospitalization, the caregiver will record AGE signs in a diary. The CRFs' paper versions of the symptoms diaries that the caregivers completed will be transferred by the physician to the physician's paper versions of the CRFs following completion of the study. In Statistical Analysis System software, an electronic database and CRFs will be created. Sample size: The Altman nomogram was used to determine the sample size of experimental and control groups. A sample of 110 patients will be required to demonstrate a statistically relevant difference of 24 hours in the duration of AGE symptoms in experimental and control groups, with a 5% significance level and a power of 90%, with a 5% significance level and a power of 90 percent, assuming that the standard deviation of the measure in each group of 40 h. If the p-value of the Shapiro-Wilk test is > 0. 05, the comparison of group A and B in terms of the primary endpoint will be conducted with Student's t-test will be conducted. The Chi-squared questionnaire, or Fisher's exact test, will be used to compare the A and B groups in terms of adverse events and diarrhea severity. The COVID pandemic had a significantly reduced number of patients hospitalized in our hospital in the corresponding months. We've made the following revisions to the protocol: For the listed reasons, we've made the following changes to the protocol: The first version of the protocol allowed for the recruitment of patients among hospitalized children only. The Emergency Department was among the four other clinics of the Pediatric Teaching Clinical Hospital at the Medical University of Warsaw that were included in the new bill. The amendment added two new departments for patient recruitment: Warsaw Children's Hospital and the Department of Pediatrics of Hospital of Trzebnica, Poland, and the Department of Pediatrics.
Source link: https://clinicaltrials.gov/ct2/show/NCT03988257
* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions