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IRCT20180228038895N1 IRCT 2018-09-26 Rasht University of Medical Sciences Effect of Synbiotics on Neonatal hyperbilirubinemia Therapeutic effects of Synbiotics plus phototherapy on decreasing bilirubin level in 3-14 day old icteric Neonates with gestational age >35 weeks and comparison with only phototherapy theraputic effect 2018-10-12 anticipated 194 Complete https://irct.ir/trial/29892 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment will be based on random blocks of size 4, Blinding description: In this Study, the parents of participants are unaware of the type of drug used (synbiotic or placebo).The main investigator is blind. One of the personnel is reponsible for prescribe and secretly record the type of medication.Residents and other nurses are responsible for collecting data.The data analyst also announces the results in terms of group A, B. The person who evaluate effect of Synbiotic also has no information on the type of prescription drug in every patient. 3 neonatal hyperbilirubinemia and symbiotic effect on its treatment. Intervention 1: Intervention group will receive 5 drops of oral Pedilact before breast feeding, once a day, until the day of discharge in addition to routine phototherapy,. Pedilact is a Synbiotic and contains three types of probiotic including Lactobacillus rotieri, Lactobacillus romansus and Bifidobacterium infantis and a prebiotic. It is produced by Iran zist takhmir Company. Intervention 2: Control group will receive five drops of diluted formulas once a day as placebo before breastfeeding until the day of discharge in addition to routine phototherapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because it is not compulsory at the moment.It is a new process. I do not know the publish process either
public Seyedeh Azadeh Hosseini Nouri
Siadati Alley. Namjoo Street. Gaz Square
Rasht Iran (Islamic Republic of) 000000000000 +98 13 3336 9026 dr.azadehoseini@gums.ac.ir Rasht University of Medical Sciences scientific Seyedeh Azadeh Hosseini Nouri
Siadati Alley. Namjoo Street. Gaz Square
Rasht Iran (Islamic Republic of) 0000000000 +98 13 3336 9026 dr.azadehoseini@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Age between 3-14 days Total bilirubin between 15-22 mg/dl and direct bill <1.5 Exclusive breast feeding Without underlying disease Weight>2500gr 3 days 14 days Both Sepsis Cephalhematoma ABO incompatibility G6PD deficiency Underlying disease Parental dissatisfaction Polycythemia RH incompatibility Formula feeding Treated by Phenobarbital .billinaster.etc... Transfer to NICU Down Syndrome Family history of Immune deficiency Blood exchange Treated by Antibiotics Serum therapy Hemolysis Diabetes in Mother Treatment - Drugs Placebo Intervention group will receive 5 drops of oral Pedilact before breast feeding, once a day, until the day of discharge in addition to routine phototherapy,. Pedilact is a Synbiotic and contains three types of probiotic including Lactobacillus rotieri, Lactobacillus romansus and Bifidobacterium infantis and a prebiotic. It is produced by Iran zist takhmir Company Control group will receive five drops of diluted formulas once a day as placebo before breastfeeding until the day of discharge in addition to routine phototherapy. Bilirubin level. Timepoint: Measurement of Bilirubin in admission day and daily until discharge(8 AM). Method of measurement: Measurement of serum bilirubin in laboratory by Pars Azmoon kits. Daily defecation numbers. Timepoint: Daily at 8 AM until discharge. Method of measurement: Question from parents. Rasht University of Medical Sciences Approved 2018-07-26 Ethics committee of Guilan University Of Medical Sciences Siadati Ave, Namjoo Blvd Rasht Guilan Iran (Islamic Republic of)