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IRCT20220425054648N1 IRCT 2022-06-24 National Nutrition & Food Technology Research Institute Bovine colostrum and acute respiratory failure "The effect of enteral bovine colostrum supplement on outcomes of critically ill patients with acute respiratory failure 2022-07-01 anticipated 90 Complete https://irct.ir/trial/63237 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomly assign eligible individuals to two groups, the stratified blocked randomization method is used. The size of the blocks is 4, with two allocations to the intervention group (A) and two allocations to the placebo group (B), which creates 6 different permutations BAAB, BABA, ABBA, BBAA, ABAB, AABB. Randomization is performed using computer software, Blinding description: Patients in the intervention group receive 20 grams of bovine colostrum powder daily with enteral high protein formula and patients in the control group are fed only with enteral high protein formula.Colostrum and a similar amount of isocaloric enteral formula are weighed by a non-researcher using a digital scale. Colostrum and formula are similar in texture and appearance. It is then poured into small bags and coded as A and B so that the researcher and patient are not aware of the type of formula received in each group. 3 Respiratory Failure. Intervention 1: Control group: Patients in this group receive 20 grams of enteral high protein formula (Karen Pharma & Food Supplement, Co., Tehran, Iran) once a day for a minimum of 5 days and a maximum of 10 days as a placebo, which is similar in appearance, color and texture to bovine colostrum powder. Intervention 2: Intervention group: Patients in this group receive 20 grams of bovine colostrum supplement (Global Nature, New Zealand) daily for a minimum of 5 days and a maximum of 10 days. This supplement is similar to the received enteral protein formula in terms of appearance, color and texture. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Elham Rouhelhami
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 elham.roohelhami@gmail.com Shahid Beheshti University of Medical Sciences scientific Zahra Vahdat Shariatpanahi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 nutritiondata@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with acute respiratory failure Completion of informed consent form by the patient or legal guardian Feeding by enteral nutrition 18-65 years old Body Mass Index less than 35 kg/m2 18 years 65 years Both No metastatic cancer or end stage disease Lack of intolerance to milk (lactose) Don't participate in other clinical trial studies at the same time as the present study J96.9 Respiratory failure, unspecified Other Prevention Control group: Patients in this group receive 20 grams of enteral high protein formula (Karen Pharma & Food Supplement, Co., Tehran, Iran) once a day for a minimum of 5 days and a maximum of 10 days as a placebo, which is similar in appearance, color and texture to bovine colostrum powder. Intervention group: Patients in this group receive 20 grams of bovine colostrum supplement (Global Nature, New Zealand) daily for a minimum of 5 days and a maximum of 10 days. This supplement is similar to the received enteral protein formula in terms of appearance, color and texture. Incidence of nosocomial infection. Timepoint: The incidence of nosocomial infection is assessed up to 3 days after discharge from the hospital. Method of measurement: The incidence of nosocomial infection is based on the results of laboratory tests and medical records. The Mean concentration of serum CD markers (CD4, CD8). Timepoint: The CD markers (CD4, CD8) variable are measured at the beginning and end of the intervention. Method of measurement: Evaluation of CD marker variables (CD4, CD8) are performed using ELISA method and related kits. The Mean concentration of serum Insulin-like Growth Factor1. Timepoint: The Insulin-like Growth Factor1 variable is measured at the beginning and end of the intervention. Method of measurement: Evaluation of Insulin-like Growth Factor1 is performed using ELISA method and related kits. Duration of hospitalization in the hospital, duration of hospitalization in the intensive care unit. Timepoint: The evaluation of these variables is from the beginning of the intervention to the time of hospitalization of the patient in the hospital and intensive care unit. Method of measurement: The evaluation of these variables is based on the information recorded in the patients' hospital records. Patient mortality rate in hospital and intensive care unit. Timepoint: The evaluation of these variables is from the beginning of the intervention to the time of possible death of the patient in the hospital and intensive care unit. Method of measurement: The evaluation of these variables is based on the information recorded in the patients' hospital records. Gastrointestinal complications (diarrhea, constipation, nausea, abdominal distension). Timepoint: Evaluation of these variables is from the beginning of the intervention to the end of the intervention. Method of measurement: Based on reports recorded in the patient's file. National Nutrition & Food Technology Research Institute Approved 2022-03-14 Ethics committee of Shahid Beheshti University of Medical Sciences No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)