To evaluate the impact of probiotics on serum billirubin we give pedilavt drop to 150neonate.We include who is term, healthy and weigh more than 2500 gram and exclude whom has blood group incompatibility,Rh incompatibility and G6PD deficiency and other risk factods.Study group is given pedilact drop 10 drop per day plus phototherapy and control group is given only phototherapy. serum bilirubin level is taken at admission,24,48 and 72 hours later and number of admission days will be record and then results will be compared to determin the impact of probiotics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032333129N1
Registration date:2017-05-30, 1396/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-30, 1396/03/09
Registrant information
Name
Abes Ahmadi Jazi
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 2151
Email address
abes.ahmadi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Science
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotics with phototherapy in compare to phototherapy for reduction of bilirubin in term neonates
Public title
Effect of probiotics on treating neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : term; healthy; age less than 28 day and more than 1day;weight more than 2500 grams;
Exclusion criteria : ABO incompatibility;Rh incompatibility; G6PD deficiency, weight below 2500 gr; history of exchange transfusion in previous sibling; use of drugs such as Phenobarbital during pregnancy; drug and home remedy for jaundice; gestational age less than 37 completed weeks;
Age
To 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Babol University of Medical Science
Street address
Keshavarz boulevard
City
Babol
Postal code
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
MUBABOL.HRI.REC.1395.80
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified:Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Serum billirubin level in study group
Timepoint
At admission serum billirubin level
Method of measurement
mg/dl , device: bilitest A from tajhizat sanjesh company
2
Description
Serum billirubin level in study group
Timepoint
Second day serum billirubin level
Method of measurement
mg/dl , device: bilitest A from tajhizat sanjesh company
3
Description
Serum billirubin level in study group
Timepoint
Third day serum billirubin level
Method of measurement
mg/dl , device: bilitest A from tajhizat sanjesh company
4
Description
Serum billirubin level in study group
Timepoint
Forth day serum billirubin level
Method of measurement
mg/dl , device: bilitest A from tajhizat sanjesh company
5
Description
Serum billirubin level in contrl group
Timepoint
At admission serum billirubin level
Method of measurement
mg/dl , device: bilitest A from tajhizat sanjesh company
6
Description
Serum billirubin level in contrl group
Timepoint
Second day serum billirubin level
Method of measurement
mg/dl , device: bilitest A from tajhizat sanjesh company
7
Description
Serum billirubin level in contrl group
Timepoint
Third day serum billirubin
Method of measurement
mg/dl , device: bilitest A from tajhizat sanjesh company
8
Description
Serum billirubin level in contrl group
Timepoint
Forth day serum billirubin level
Method of measurement
mg/dl , device: bilitest A from tajhizat sanjesh company
Secondary outcomes
1
Description
Duration of admission in control group
Timepoint
At discharge
Method of measurement
Day
2
Description
Need of blood exchang transfusion in control group
Timepoint
At discharge
Method of measurement
No
3
Description
Need of blood exchang transfusion in control group
Timepoint
At discharge
Method of measurement
Yes
4
Description
Need of blood exchang transfusion in study group
Timepoint
At discharge
Method of measurement
No
5
Description
Duration of admission in study group
Timepoint
At discharge
Method of measurement
Day
6
Description
Need of blood exchang transfusion in study group
Timepoint
At discharge
Method of measurement
Yes
Intervention groups
1
Description
Administration of probiotics to study group
Pedilact drop from Zist Takhmir Company
10 drop/day
Category
Treatment - Drugs
2
Description
control group is given only phototherapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children's Hospital
Full name of responsible person
Dr Abes Ahmadi Jazi
Street address
Amirkola Emam Boulvard
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Mrs Moslem Nejad
Street address
Keshavarz boulvard
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Science
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
Babol University of Medical Science
Full name of responsible person
Dr Abes Ahmadi Jazi
Position
Felowship resident of neonatalogy
Other areas of specialty/work
Street address
Amirkola Emam Boulvard
City
Babol
Postal code
Phone
+98 11 3234 2151
Fax
Email
Abesahmadijazi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Dr Yadollah Zahed Pasha
Position
Neonatalogist
Other areas of specialty/work
Street address
Amirkola Emam Boulvard
City
Babol
Postal code
Phone
+98 11 3234 2151
Fax
Email
Zypasha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Dr Abes Ahmadi Jazi
Position
Felowship resident of neonatalogy
Other areas of specialty/work
Street address
Amirkola Emam Boulvard
City
Babol
Postal code
Phone
+98 11 3234 2151
Fax
Email
Abesahmadijazi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)