In a randomized clinical trial, 60 term(GA 35-37wks) newborns with 24-120 hours age; serum billirubin level 14-20 mg/dl; birth weight 2500-4000 grams; exclusively breast fed; direct bilirubin<2mg/dl and without karnictros symptoms; hemolysis ; need for blood exchange; sepsis or history of any treatment for jaundice before hospitalization, randomly divided in 3 groups (20 newborns in each group)The first group receive billineaster 5drops/kg every 8hrs; the second group receive glycerin 1/2 suppository every 12hrs; and third group is control. For all three groups, phototherapy will be done with the same conditions. Total serum bilirubin level will be assayed 12, 24, 36 and 48 hours after initiation of treatment in all three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031312807N1
Registration date:2013-05-01, 1392/02/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-01, 1392/02/11
Registrant information
Name
Mohammad Ali Fallahzadeh
Name of organization / entity
Shaheed Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4000
Email address
drfallahzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research -Shaheed Sadoughi University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Billineaster drop and Glycerin suppository on the neonatal jaundice
Public title
Billineaster and glycerin in neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 24-120 hrs; gestational age:term(37-42weaks); birth weight: 2500-4000 grams; breast feeding exclusively; total serum billirubin 14-20 mg/dl; no symptoms of kernicterus and not receiving any treatment (phototherapy, billineaster ,glycerin,...) before hospitalization.
Exclusion criteria: hemolysis or sepsis; need for blood exchange and weight loss >5%.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Sadoughi University of Medical Sciences and Health Services
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2011-10-10, 1390/07/18
Ethics committee reference number
17/1/97215/پ
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Serum total billirubin
Timepoint
Every 12 hours until 48 hours
Method of measurement
Labratory tast
Secondary outcomes
1
Description
Fequency of deffication
Timepoint
Daily
Method of measurement
Clinical
2
Description
Weight
Timepoint
Daily
Method of measurement
With scale
3
Description
Duration of hospitalization
Timepoint
At discharge
Method of measurement
From admission to discharge
Intervention groups
1
Description
Billineaster 5 drop/kg q8hr, until 48hrs.
Category
Treatment - Drugs
2
Description
Glycerin suppository 1/2 q12hrs until 48hrs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital h- nicu
Full name of responsible person
Dr Mahmood Noori Shadkam
Street address
Yazd - Ibn sina ave
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research -Shaheed Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Fatemah Ezodinee
Street address
Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research -Shaheed Sadoughi University of Medical Sciences
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
Shaheed Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Ali Fallahzadeh
Position
MD, resident of pediatric disease
Other areas of specialty/work
Street address
Shahid Bahonar sq.
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drfallahzadeh@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Mahmood Noori Shadkam
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
noorishadkam@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Ali Fallahzadeh
Position
MD, resident of pediatric disease
Other areas of specialty/work
Street address
Shahid Bahonar sq.
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drfallahzadeh@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)