This study is aimed to compare the therapeutic effect of Phototherapy with Bili Cuttermana and Phototherapy alone and Phototherapy with bilinaster in the treatment of neonatal jaundice. 350 neonates with hyperbilirubinemia who were admitted at neonatal ward after entering the study are randomly divided into six case and one control groups. Infants in each group are 50. Control group only treated with phototherapy but Intervention group one, infant received Bili Cuttermana 5 drops per kg of body weight three times a day in addition to the phototherapy. Group two, infant received Bilineaster 5 drops per kg of body weight three times a day in addition to the phototherapy. Group three, infant and her/his mother received Bilikatermana 2 drops per kg of body weight three times a day in addition to the phototherapy (infant). Group four, infant and her/his mother received Bilineaster 2 drops per kg of body weight three times a day in addition to the phototherapy (infant). Group five, infants mother received Bili Cuttermana 5 drops per kg of body weight three times a day in addition to the phototherapy (infant). Group six, infants mother received Bilineaster 5 drops per kg of body weight three times a day in addition to the phototherapy (infant). Daily bilirubin levels and mean levels of bilirubin in the first day to the last day (to reach bilirubin level of 10 mg / dl) of the two groups are measured and compared. The mean duration of hospitalization is calculated and compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120425203N2
Registration date:2016-02-18, 1394/11/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Hamidreza Aghababaeian
Name of organization / entity
Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 9733
Email address
aghababaeian.h@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dezful University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of Billynaster and Billy Cuttermana on decreasing jaundice in neonates
Public title
The survey of the effect of Billy Cuttermana on decreasing jaundice in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy term breast-fed infants weighing 2.5 to 4 Kg after 36 hours until 14 days developed jaundice and photo therapy indicated.
Exclusion criteria: per-and post term infants; formula feeding; the presence of any malformations and associated diseases such as sepsis; weighing less than 2.5 and more than 4 kg; neonates developed jaundice after 14 days who need Intensive photo therapy or exchange; ABO or RH incompatibility; presence direct hyper bilirubinemia.
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:
350
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dezful University of Medical Sciences
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran
City
Dezful
Postal code
Approval date
2015-08-21, 1394/05/30
Ethics committee reference number
Ir.dums.rec.1394.9
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
Bilirubin
Timepoint
On arrival at the hospital, 12, 24, 48, 72 hours after it
Method of measurement
Bailey Test milligrams per deciliter
Secondary outcomes
1
Description
Bilirubin
Timepoint
12, 24, 48, 72 hours after it
Method of measurement
Bailey Test milligrams per deciliter
Intervention groups
1
Description
Control group only treated with photo therapy
Category
Early detection
2
Description
Intervention group one, infant received Bilikatermana 5 drops per kg of body weight three times a day in addition to the phototherapy
Category
Treatment - Drugs
3
Description
Group two, infant received Bilineaster 5 drops per kg of body weight three times a day in addition to the phototherapy
Category
Treatment - Drugs
4
Description
Group three, infant and her/his mother received Bilicatermana 2 drops per kg of body weight three times a day in addition to the phototherapy (infant)
Category
Treatment - Drugs
5
Description
Group four, infant and her/his mother received Bilineaster 2 drops per kg of body weight three times a day in addition to the phototherapy (infant)
Category
Treatment - Drugs
6
Description
Group five, infants mother received Bilikatermana 5 drops per kg of body weight three times a day in addition to the phototherapy (infant)
Category
Treatment - Drugs
7
Description
Group six, infants mother received Bilineaster 5 drops per kg of body weight three times a day in addition to the phototherapy (infant)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dezful Hospital, Dezful University Of Medical Sciences
Full name of responsible person
Feridon Nirozad
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezful University Of Medical Sciences
Full name of responsible person
Feridon Nirozad
Street address
Next The Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran
City
Dezful
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezful 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
Dezful University Of Medical Sciences, Dezful, Iran
Full name of responsible person
Hamidreza Aghababaeian
Position
Faculty Member
Other areas of specialty/work
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran
City
Dezful
Postal code
Phone
+98 61 4242 9733
Fax
Email
AGHABABAEIAN.H@DUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezful University Of Medical Sciences, Dezful, Iran
Full name of responsible person
Hamidreza Aghababaeian
Position
Faculty Member
Other areas of specialty/work
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran
City
Dezful
Postal code
Phone
+98 61 4242 9531
Fax
Email
RESEARCH@DUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dezful University Of Medical Sciences, Dezful, Iran
Full name of responsible person
Hamidreza Aghababaeian
Position
Faculty Member/ Master degree
Other areas of specialty/work
Street address
Next to the Police Department, Azadegan Blv, Dezful University of Medical Sciences, Dezful, Khozestan, Iran
City
Dezful
Postal code
Phone
+98 61 4242 9733
Fax
Email
AGHABABAEIAN.H@DUMS.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)