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IRCT20170121032075N2 IRCT 2019-07-29 Mashhad University of Medical Sciences The effect of probiotics on prevention of necrotizing enterocolitis in neonates Study of the effect of probiotics on prevention of necrotizing enterocolitis in preterm infants 2017-08-23 anticipated 64 Complete https://irct.ir/trial/25078 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was carried out simply. The allocation of newborns to the intervention and control groups is as follows: the study population will be randomly selected by computer. This study will be blinded in triplicate. Based on the randomization table arranged by the computer, the intervention and control group will be placed inside the matched envelopes and will be inserted, Blinding description: The researcher, parents and the collaborator of the project who will perform ‎the statistical analysis will not be aware of the study . grouping of patients will ‎be noted and will be shared to one of the partners ‎. 3 Necrozen enterocolitis is the most common gastrointestinal emergency in premature infants. Intervention 1: Intervention group: The infants received podilactok probiotics in a dose of 1 drops per kg of body weight every 12 hours ‎with breast milk or milk powder . Intervention 2: Control group: The control group received 0.5 cc normal saline every 12 hours along with a type of infant or breast milk. Yes - There is a plan to make this available What will be shared: En A part of the questionnaire information that ‎relates to patient information is shared.‎ When: Start the access period after printing the results To whom: Available to academic and academic researchers Conditions: After publishing it as a paper for the public and ‎researchers from academic medical institutions Where to obtain: ISI and Google How to obtain: In search sites, the use of Probiotics, Preterm newborn, Necrotizing enterocolitis Comments:
public Mir Farhad Mirmohammdi
Ibn sina Ave- Imam Reza hospital- Mashhad- Iran
Mashahd Iran (Islamic Republic of) 9137913316 +98 51 3852 1121 mirmohammadif951@mums.ac.ir Mashhad University of Medical Sciences scientific mir farhad mirmohammdi
Ibn sina ave- imam reza hospital- mashhad- Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3852 1121 mirmohammadif951@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) VLBW infants (gestational age ≤ 34 weeks and birth weight ≤ 1500 g) survive until oral nutrition begins. 1 day 30 days Both Severe asphyxia (stage III) Congenital major anomalies Babies who have not started oral feeding for 3 weeks after birth Infants receiving antifungal treatment A04.7 Enterocolitis due to Clostridium difficile Treatment - Drugs Treatment - Drugs Intervention group: The infants received podilactok probiotics in a dose of 1 drops per kg of body weight every 12 hours ‎with breast milk or milk powder . Control group: The control group received 0.5 cc normal saline every 12 hours along with a type of infant or breast milk Birth weight. Timepoint: before intervention in time of birth. Method of measurement: Kilogram. Weight. Timepoint: after intervention. Method of measurement: Kilogram. Mashhad University of Medical Sciences Approved 2018-05-23 Ethics committee of Mashhad University of Medical Sciences Ghoreyshi Bul- daneshgah Ave- Mashhad University of medical sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)