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IRCT20141028019716N5 IRCT 2022-08-05 Bojnourd University of Medical Sciences The effect of probiotics on enteral milk tolerance and prevention of Necrotizing Enterocolitis in preterm infants hospitalization NEC The effect of probiotics on enteral milk tolerance and prevention of Necrotizing Enterocolitis in preterm infants hospitalization 2022-07-21 anticipated 30 Complete https://irct.ir/trial/64715 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: In the clinical trial studies, using the tables for the preparation of samples, considering five items, which include: 1- The difference in treatment responses that should be taken 2- The estimation of the amount of treatment responses in one of the groups under research 3- The amount of significant difference Statistics (α), 4- the desired strength of the research (β-1) and 5- whether the experiment is one-sided or two-sided, the sample size in each group is estimated.In this study, the researcher expects a 30% difference in milk tolerance in the two intervention and control groups, and considering the 10% milk tolerance [R1] in the control group and considering the type 1 error (α) of 0.05 and the power of the study (β-1) 80% and taking into account one-sided tests in examining the difference and relationship between groups, the sample size is 30 people in each group and taking into account 30% dropout (n*0.1.1 3), 43 people will be examined in each group, Randomization description: According to the size of the samples, 30 babies will be identified by random block method with 4 blocks and using random numbers table of Random Allocation Software. Blocking and allocation sequence for concealment will be done by a person not involved in the research. The allocation ratio of the samples will be 1:1 and it will be divided into two groups receiving the product of biofermentation company and the control group. This study is double-blind and blinding will take place, Blinding description: Before the start of the study, solution A and B will be provided to the study administrator by Biot Khamtir, who will be the participant, researcher, healthcare personnel (doctors, nurses), clinical supervisor, and outcome evaluator until the end of the study. Except for the manufacturer of the solution, they are blind and do not know which of the mentioned solutions is drug or non-drug. 3 and prevention of Necrotizing Enterocolitis in preterm. Intervention 1: intervention group: After the baby's feeding volume reaches 5 cc/kg/d, oral probiotics from Bio Fermentation Company at the rate of one drop per kilogram of body weight with normal saline solution up to a volume of 5. cc diluted, administered every 12 hours. Intervention 2: In the control group: Only equivalent to 5/. CC of normal saline solution was administered every 12 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is Need for more studies
public Dr. Ghasem Bayani
North Khorasan ,bojnord,bernji allley
Bojnord Iran (Islamic Republic of) 2247124 +98 58 4221 1008 bayani.ghasem@yahoo.com Bojnourd University of Medical Sciences scientific Dr. Ghasem Bayani
North Khorasan ,bojnord,bernji allley
Bojnord Iran (Islamic Republic of) 2247124 +98 58 4221 1008 bayani.ghasem@yahoo.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Entry condition for pregnancy age below 30 weeks and birth weight less than 1500 grams 168 months 210 days Both Babies with gastrointestinal obstruction, congenital heart disease, amphalocele, gastroschisis, grade 2 and 3 asphyxiaCommunity Verified icon Babies of addicted mothers(Because one of the problems of babies born to addicted mothers is digestive problems such as feeding intolerance and abdominal distention and diarrhea, which can overlap with the symptoms of necrotizing enterocolitis).Community Verified icon Failure to receive enteral nutrition in the first 48 hours of birth Death of a premature baby Congenital and chromosomal malformations in the digestive system of premature babies Active gastrointestinal bleeding in the first week after birth P77.9 Necrotizing enterocolitis in newborn, unspecified Prevention Prevention intervention group: After the baby's feeding volume reaches 5 cc/kg/d, oral probiotics from Bio Fermentation Company at the rate of one drop per kilogram of body weight with normal saline solution up to a volume of 5. cc diluted, administered every 12 hours In the control group: Only equivalent to 5/. CC of normal saline solution was administered every 12 hours. Prevention of necrotizing enterocolitis. Timepoint: When a premature baby is hospitalized. Method of measurement: Definitive diagnosis of necrotizing enterocolitis by a neonatologist. 1. Duration of hospitalization. Timepoint: Weight of premature baby at admission and at discharge. Method of measurement: The weight of the premature baby is in grams at the time of hospitalization And the time is based on hours and minutes and Increase in head circumference based on centimeters. Bojnourd University of Medical Sciences Approved 2022-06-26 Research Ethics Committee of North Khorasan University of Medical Sciences honar Street,Bent Al Hadi Hospital bojnurd North Khorasan Iran (Islamic Republic of)