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IRCT20180519039715N2 IRCT 2019-10-06 Kermanshah University of Medical Sciences The role of synbiotic in the prevention of necrotizing enterocolitis in preterm neonates. The role of synbiotic in the prevention of necrotizing enterocolitis in preterm neonates. 2018-09-23 anticipated 118 Complete https://irct.ir/trial/41754 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed by assigning one to one according to the neonatal medical record number. The neonate with the even case number were assigned to the intervention group and the neonate with the odd case number were assigned to the placebo group, Blinding description: In this study, the parents of the participants were blind and unaware of the type of drug (synbiotic or placebo).The main researcher is blind. One of the staff is responsible for prescribing and secretly prescribing the drug and the resident and the other nurse are responsible for data collection.The data analyzer also announces the results in groups A and B. The efficacy evaluator is also unaware of the type of medication prescribed for each patient. 1 Necrotizing enterocolitis. Intervention 1: Intervention group: 1/25 cc/kg/day oral synbiotic (Made by bio-fermentation Co. in IRI, 1/25 cc synbiotic combination consisting of probiotic compounds contains Lactobacillus reuteri 4*108 CFU, Lactobacillus rhamnosus 2*109 CFU, Bifidobacterium infantis 3*108 CFU and prebiotic compounds including Fructooligosaccharides (FOS) 3% and other ingredients including Sunflower oil, MCT oil (Medium-chain triglycerides), Silicon dioxide (SiO2) and Natural flavor). Intervention 2: Control group: 1/25 cc/kg/day oral distilled water as placebo (placebo sachet with the same shape and color to symbiotic). No - There is not a plan to make this available Justification or reason for not sharing IPD is Adherence to study ethical standards
public Amir Shahidolahi
Bagh Abrisham Blvd, Imam Reza Hospital
Kermanshah Iran (Islamic Republic of) 6719851451 +98 83 3826 4513 d.p_2011@yahoo.com Kermanshah University of Medical Sciences scientific Homa Babaei
Bagh Abrisham Blvd, Imam Reza Hospital
Kermanshah Iran (Islamic Republic of) 6719751451 +98 83 3826 4513 Homa_babaei@Kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Admission to the Neonatal Intensive Care Unit (NICU) at birth Gestational age less than 34 weeks (early preterm) Elapse of maximum 28 days after birth birth weight 1000 to 1500 gr Lack of affliction with gastrointestinal obstruction, amphalocele, gastroschis, congenital heart disease, clinical or proven sepsis, grade 2 and 3 asphyxia No history of immunodeficiency among relatives No maternal drug addiction Avoidance of breast-feeding to feed neonate Avoidance of synbiotic supplementation consumption by the infant mother 1 day 28 days Both Gestational age over 34 weeks Elapse of over 28 days since the birth of infant Birth weight less than 1000 (due to high mortality rates) and more than 1500 gr Neonate’s affliction with gastrointestinal obstruction, amphalocele, gastroschis, congenital heart diseases, clinical or proven sepsis, grade 2 and grade 3 asphyxia History of immunodeficiency among relatives Neonate with addicted mother Babies fed with powdered milk Oral administration of synbiotic supplement by neonate’s mother P77 Necrotizing enterocolitis of newborn Prevention Placebo Intervention group: 1/25 cc/kg/day oral synbiotic (Made by bio-fermentation Co. in IRI, 1/25 cc synbiotic combination consisting of probiotic compounds contains Lactobacillus reuteri 4*108 CFU, Lactobacillus rhamnosus 2*109 CFU, Bifidobacterium infantis 3*108 CFU and prebiotic compounds including Fructooligosaccharides (FOS) 3% and other ingredients including Sunflower oil, MCT oil (Medium-chain triglycerides), Silicon dioxide (SiO2) and Natural flavor). Control group: 1/25 cc/kg/day oral distilled water as placebo (placebo sachet with the same shape and color to symbiotic). Duration to reach full oral nutrition (150 cc kg/day). Timepoint: Measuring the time from birth to reach the age of full oral nutrition (150 cc/kg/day). Method of measurement: Asking parents. Breast feeding tolerance. Timepoint: Measuring the amount of breast milk consumed per day and then daily until discharge. Method of measurement: Asking parents. Necrotizing enterocolitis. Timepoint: Measurement from birth to discharge and daily. Method of measurement: Stage 1 (suspicion to enterocolitis): The symptoms include apnea, lethargy, bloody stool, abdominal distension, temperature instability, the residue in the stomach, lack of radiologic evidence. Stage 2 (proven enterocolitis): Symptoms of stage I + thrombocytopenia ± mild metabolic acidosis, abdominal tenderness, and presence of pneumatosis or gas in the portal vein. Stage 3 (advanced enterocolitis): Symptoms of stage 2 + hypotension, bradycardia, severe apnea, metabolic and respiratory acidosis, diffuse intravascular coagulation, clear abdominal tenderness, neutropenia, pneumoperitonitis. Kermanshah University of Medical Sciences Approved 2018-03-14 Ethics committee of Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti Blvd, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)