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Study aim
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Evaluation and comparison of two probiotic drugs, Pedilact, Reuteflor and placebo, on the days of reaching full feeding volume , hospitalization days , days of need for oxygen therapy , daily weight gain , the incidence of necrotizing enterocolitis and neonatal jaundice in preterm neoates
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Design
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Clinical trial with control group, with parallel groups, triple blind, randomized, phase 3 on 90 patients
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Settings and conduct
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Neonatal intensive care unit of Valiasr Hospital in Birjand,
the neonates are randomly divided into three groups of numbers and each group is prescribed 5 drops of Pedilact or Reuteflor or distilled water daily for 7 days.Lack of information of the patient and medical staff involved and responsible for data collection and data analyzer of the type of drug or placebo
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Premature neonates (gestational age less than 37 weeks) with age from birth to 7 days of age at the time of feeding start with a weight of 1000 to 2000 grams and non-inclusion conditions: severe asphyxia, cerebral hemorrhage, congenital anomaly major, Premature neonatal sepsis
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Intervention groups
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In each random group, preterm neonates are given 5 drops of the drug or placebo specific to that group for 7 days from the start of oral feeding.
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Main outcome variables
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Duration of hospitalization, time to Full enteral feeding, duration of oxygen therapy