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IRCT20171218037936N1 IRCT 2018-03-05 Oroumia University of Medical Sciences Evaluation of the effect of probiotics on late-onset sepsis in very preterm newborns Evaluation of the effect of probiotics on late-onset sepsis in very preterm newborns 2017-02-19 anticipated 84 Complete https://irct.ir/trial/29386 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: randomization will be as balanced (permuted) block randomization. Sample size was determined based on previous studies with respect to d = 10% and P = 0.7 and α = 0.05 in each group of 42 people in a total of 84 people. According to the sample size, and block size of 6 (AAABBB), 14 blocks will be selected. Initially, all possible six-point permutations will be listed, and then each will be assigned a code, and in the sequel, 14 of these codes will be selected as lotteries, followed by the corresponding combinations with each of the selection codes Listed and individuals will be assigned to the corresponding groups, Blinding description: The groups under study are two groups .The probiotic will be used for intervention group and placebo for the control group. Each participant will be assigned a code that will remain secret until the end of the study. To ensure that the type of substance received are not identified, a placebo and probiotic substance will be provided in one form and in the same vials . 3 late-onset sepsis in very preterm infants. Intervention 1: Intervention group: 42 preterm infants with a gestational age of less than 32 weeks and a weight of between 1,000-1,500 g and matched with clinical inclusion criteria for the study randomly assigned and recived one drop per kilogram of body weight of probiotic(Pedilact droplet of Zist takhmir Company) solution twice daily. Intervention 2: Control group: 42 preterm infants with a gestational age of less than 32 weeks and a weight of between 1,000-1,500 g and matched with clinical inclusion criteria for the study randomly assigned and recived one drop per kilogram of body weight of Dish water twice daily. Yes - There is a plan to make this available What will be shared: All data forms potentially can be shared after unidentifiable individuals. When: The access period start one year after the print results To whom: Only for researchers working in academic and academic institutions Conditions: In the case of scientific authentication, information will be provided to them Where to obtain: Dr. Siamak Karimi’s Email( Pediatric Resident) siamack.karimi@gmail.com How to obtain: Upon receipt of the email, the request will be contacted by the applicant Comments:
public Siamack Karimi Heydarabad
Motahhari hospital, Kashani Av Urmia Vest Azarbaijan Iran, Islamic Republic Of
Urmia Iran (Islamic Republic of) 57147 +98 44 3223 7078 siamack.karimi@gmail.com Oroumia University of Medical Sciences scientific Dr Kamran Dehghan
Motahhari hospital, Kashani Av Urmia, Vest Azarbaijan Iran, Islamic Republic Of
Urmia Iran (Islamic Republic of) 57147 +98 44 3223 7078 dr_kamrandehghan@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Preterm infants weighting 1000-1500 g and less than 32 weeks’ gestational age at birth Enrolled within 48 hours of birth 1 day no limit Both Major congenital anomalies(Esophageal atresia,Omphalocele,Imperforate anus) Major congenital heart malformations Genetic anomalies(e.g Trisomy 21 or other trisomies) Considered likely to die within 72 hours of birth Death before minimal entral feeding(10-20cc/kg/day) Parents from whom informed consent cannot be obtained Sepsis in admission(CRP>10mg/dl in 1st day of admission) Asphyxia (grade II, III) Maternal chorioamnionitis P36.9 Bacterial sepsis of newborn, unspecified Prevention Prevention Intervention group: 42 preterm infants with a gestational age of less than 32 weeks and a weight of between 1,000-1,500 g and matched with clinical inclusion criteria for the study randomly assigned and recived one drop per kilogram of body weight of probiotic(Pedilact droplet of Zist takhmir Company) solution twice daily. Control group: 42 preterm infants with a gestational age of less than 32 weeks and a weight of between 1,000-1,500 g and matched with clinical inclusion criteria for the study randomly assigned and recived one drop per kilogram of body weight of Dish water twice daily. Late-onset sepsis. Timepoint: Baseline(admission), weekly and when clinical sepsis suspected. Method of measurement: Measurement of C-Reactive Protein and clinical clinical evaluation. Necrotizing enterocolitis. Timepoint: On admission, every week, when symptoms of Necrotizing enterocolitis are diagnosed. Method of measurement: Clinical evaluation based on Bell's Criteria. Duration of primary hospitalization. Timepoint: Time of discharge. Method of measurement: Count the number of hospitalization days. The number of days the infant takes to complete entral feeding(120mL/kg per day). Timepoint: During the study period. Method of measurement: number of days until an infant to eat 120mL / kg per day of milk. Oroumia University of Medical Sciences Approved 2017-02-08 Ethic committee of Urmia University of Medical Sciences Urmia university of medical sciences-Resalat Blvd-Emergency Alley. Urmia Vest Azarbaijan Iran, Islamic Republic Of Urmia West Azarbaijan Iran (Islamic Republic of)