The effect of Sinbiotics (Prebiotics and Probiotics) with standard phototherapy on treatment of neonatal hyperbilirubinemia with 2-14 days of age in compare with standard phototherapy
Purpose: Assessment of Sinbiotic's effect (Probiotic and Prerbiotic) on treatment of neonatal hyperbilirubinemia with 2-14 days of age.
Design: This Study is a Randomized clinical trial. Population of the study: Neonates admitted in neonatal section of Sabzevar's Heshmatie Hospital with bilirubin level more than 15 mg/dl with 2 to 14 days of age. Inclusion criteria: Neonates with 2 to 14 days of age; Neonates with serum bilirubin level more than 15 mg/dl and direct bilirubin less than 1.5 mg/dl; Neonates with normal retic count. Exclusion criteria: Neonates with low Hemoglobin and positive Glucose-6- Phosphate Dehydrogenase (G6PD) and direct Coombs. Volume of samples: In each group- control and intervention 40 neonates altogether 80 neonates enter the study. Study intervention: Control group treat with photo therapy in 3 days but in intervention group in addition to 3 days photo therapy, Sinbiotic (Probiotic and Prebiotic) like Pedilact 5 drops each day (equivalent 109 CFU of Lactobacillus reuteri, Lactobacillusrhamnosus and Bifidobacterium infantis stubs) untill 3 days have given, then serum bilirubin level checked in 1, 2 and 3 days and have recorded and then compared with control group. Intervention date: From February 11 until March 13 2017. results: If the effect of Sinbiotic has proved, we can use these products to treat neonatal Jaundice faster and reduce time of admission and economic costs and prevent from dangerous Jaundice adverse effect like Kernicterus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041933523N1
Registration date:2017-11-19, 1396/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Sorur Yari
Name of organization / entity
Sabzevar Universitry of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7733 0416
Email address
www.yaris1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2017-02-11, 1395/11/23
Expected recruitment end date
2017-03-13, 1395/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Sinbiotics (Prebiotics and Probiotics) with standard phototherapy on treatment of neonatal hyperbilirubinemia with 2-14 days of age in compare with standard phototherapy
Public title
Effect of Sinbiotic on faster treatment of neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Neonates with 2 to 14 days of age; Neonates with serum bilirubin level more than 15 milligrams per deciliter (mg/dl) and direct bilirubin less than 1.5 mg/dl; Neonates with normal retic count; Neonates do not have Cephalohematoma and Caputsuccedaneum; Neonates with more than 37 weeks gestational age; Neonates with more than 2500 grams birth weight; Neonates without Polycythemia (Hematocrit more than 65); Neonates without past medical history; Neonates without blood exchange. Exclusion criteria: Neonates with low Hemoglobin and positive Glucose-6- Phosphate Dehydrogenase (G6PD) and Direct Coombs; Neonates that have Cephalohematoma and Caputsuccedaneum; Neonates that their parents do not have satisfaction; Neonates that receive serum therapy, Antibiotic therapy and Intravenous Immunoglobulin (IVIG) therapy; Neonates that have abnormal Peripheral Blood Smear (PBS).
Age
From 2 days old to 14 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Science
Street address
Central construction of Sabzevar University of Medical Science, Asadabadi street, Sabzevar, Iran
City
Sabzevar
Postal code
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.MEDSAB.REC.1395.110
Health conditions studied
1
Description of health condition studied
Neonatal Jaundice
ICD-10 code
p59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Level of serum bilirubin
Timepoint
One, 2 and 3 days after treatment
Method of measurement
Milligram per Deciliter with laboratorial study of neonates' blood
Secondary outcomes
empty
Intervention groups
1
Description
In control group neonates treat with photo therapy in 3 days. Neonates treat with 8 lamps photo therapy systems of Tusan brand using TL 20W/52 lamps with 425-475 Nanometer (nm) wavelength and 20-25 centimeters distance for 24 hours in one day for 3 consecutive days. Then neonates' blood samples have given in 1, 2 and 3 dayes of treatment and serum bilirubin compare with intervention group.
Category
Treatment - Other
2
Description
In intervention group in addition to 3 days photo therapy, Sinbiotic (Probiotic and Prerbiotic) like Pedilact oral drop 5 drops each days (equivalent 109 Colony Forming Units (CFU) of Lactobacillus reuteri، Lactobacillus rhamnosus and Bifidobacterium infantis stubs) untill 3 days have given them. Neonates treat with 8 lamps photo therapy systems of Tusan brand using TL 20W/52 lamps with 425-475 Nanometer (nm) wavelength and 20-25 centimeters distance for 24 hours in one day for 3 consecutive days. Then neonates' blood samples have given in 1, 2 and 3 dayes of treatment and serum bilirubin compare with control group.