In this studt,The term infants with neonatal jaundice given the lack of criteria for inclusion and exclusion criteria, by an assistant collaborator fall under examination. In view of the fact that the bilirubin level is the same in both groups .Both groups of babies aged less than 10 days. The length of stay in the neonatal ward considers in the judgmeit, and the average weight and bilirubin was recorded babies Ne.wborn randomly (limited) in two groups (probiotic drops) and control group (distilled water) divided. Infants in the study group (treated), receive about 5 drops probiotics 3 times a day + phototherapy and control group instead of a drop probiotics ,distilled water + phototherapy . Defecation in the first and fourth day, are reported by Mother and nurse. The level of total serum bilirubin during the four consecutive days once venous sampling and testing methods biochemistry, measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061018974N3
Registration date:2017-07-25, 1396/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-25, 1396/05/03
Registrant information
Name
Simin Gheini
Name of organization / entity
Kermanshah University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3721 8202
Email address
s.gheini@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research,kermanshah university of Medical Sciences
Expected recruitment start date
2016-08-23, 1395/06/02
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotics effects on bilirubin level in patient with neonatal jaundice admitted in the hospital
Public title
Evaluation of probiotics effects on bilirubin level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term infants with age between 3-10 days and gestational age of 42-37 weeks , birth weight equals or more than 2500 g , and bilirubin 12.9-up mg / dL at the start of phototherapy, and fed only by breast milk.Exclusion criteria: infants with blood disorders family, having signs of hemolysis due to blood group incompatibility, internal bleeding indoors due to complications of traumatic birth (exp : cephalohematom), suspected neonatal infection such as chorioamnionitis, intrauterine infection, sepsis and urinary tract infection, perinatal hypoxic newborns, having thyroid dysfunction, distress or respiratory failure, malfunction regulate body temperature and metabolic, hemodynamic instability and congenital heart disease, a history of maternal use of phenobarbital during the last month of pregnancy venous hematocrit 65%
Age
From 1 day old to 10 days old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee kermanshah university of medical sceinces
Street address
kermanshah shahid behashti Blv number 2 building
City
kermanshah
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.KUMS.REC.1396.85
Health conditions studied
1
Description of health condition studied
neonatal hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
P59.9 Neonatal jaundice, unspecified Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
bilirubin level
Timepoint
from 1 to 4 days
Method of measurement
serum lilirubin level
Secondary outcomes
1
Description
defecations times
Timepoint
1 and 4 days
Method of measurement
mother report
Intervention groups
1
Description
Infants in the study group(treated)receive,about 5 drops probiotics 3 times a day + phototherapy
probiotic is included Lactobacillus rhamnosus
- Lactobacillus reuteri
- Bifidobacterium infanti.
Drops are produced in Iran by iran Takhmer company, and are licensed in England
conventional photitherapy :6 lamp photo mark PHilips TL 20/120 made in germany in 35 cm from patient.
Category
Treatment - Drugs
2
Description
control group: Distilled water 5 drops/3 times day+phototherapy Distilled waters are produced by shahid ghazi in 2 cc package conventional phototherapy :6 lamp photo mark PHilips TL 20/120 made in Germany in 35 cm from patient
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
mohamad kermanshahi hospital
Full name of responsible person
simin gheini
Street address
mohamad kermanshahi hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy Minister for Research and Technology
Full name of responsible person
ِDR Hamzie
Street address
kermanshah shahid behashti Blv number 2 building
City
kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Minister for Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
kermanshah university of medical sceinces
Full name of responsible person
simin gheini
Position
pediatriction
Other areas of specialty/work
Street address
Mohamad kermanshahi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3721 8204
Fax
Email
simingheini@yahoo.coms.gheini@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
kermanshah university of medical sceinces
Full name of responsible person
simin gheini
Position
pediatriction
Other areas of specialty/work
Street address
Mohamad kermanshahi Hospital
City
Kermanshah
Postal code
Phone
+98 912 348 5142
Fax
Email
simingheini@yahoo.coms.gheini@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
kermanshah university of medical sceinces
Full name of responsible person
simin gheini
Position
MD
Other areas of specialty/work
Street address
Mohamad kermanshahi Hospital
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)