This study is aimed to compare the therapeutic effect of Phototherapy with bilineaster and Phototherapy alone in the treatment of neonatal jaundice.Healthy term breast-fed infants weighing 2.5 to 4 Kg that have developed jaundice after 36 hours to 14 days and just need to phototherapy are enrolled and infants with any malformations and associated diseases such as sepsis, ABO or RH incompatibility and direct hyperbilirubinemia and who need Intensive phototherapy or exchange are excluded from study. One hundred fifty neonates with hyperbilirubinemia who were admitted at neonatal ward after entering the study are randomly divided into case and control groups. Infants in each group is 75. Control group only treated with phototherapy but Intervention group received Bilineaster 5 drops per kg of body weight three times a day in addition to the phototherapy. Phototherapy continues to reach bilirubin level of 10 mg / dl and then the babies are discharged from the hospital. Daily bilirubin levels and mean levels of bilirubin in the first day to the last day of the two groups are measured and compared. The mean duration of hospitalization is calculated and compared in both groups. We anticipate bilineaster is effective in the treatment of jaundice, leading to a reduction in the duration of phototherapy and hospital stay .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110710933N2
Registration date:2014-05-12, 1393/02/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-12, 1393/02/22
Registrant information
Name
Fatemeh Eghbalian
Name of organization / entity
Hamadan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 3978
Email address
eghbalian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-05-01, 1394/02/11
Expected recruitment end date
2015-05-01, 1394/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of Phototherapy with bilineaster and Phototherapy alone in the treatment of neonatal jaundice
Public title
Evaluation of bilineaster effects in the treatment of neonatal jaundice
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 phototherapy indicated.
Exclusion criteria:pre-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 phototherapy or exchange ; ABO or RH incompatibility ;presence direct hyperbilirubinemia
Age
No age limit
Gender
Both
Phase
3
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
Ethics committee of Hamadan Univercity Of Medical Sciencse
Street address
Shahid Fahmide Ave,Hamadan Univercity Of Medical Sciencse, Hamedan, Iran
City
Hamedan
Postal code
6516837634
Approval date
2014-02-01, 1392/11/12
Ethics committee reference number
د/پ/16/35/9/3569
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.8
ICD-10 code description
Neonatal jaundice from other specified causes
Primary outcomes
1
Description
Indirect bilirubin
Timepoint
During 24, 48 and 72 hours after beginning of phototherapy
Method of measurement
Measuring serum bilirubin(diazo method)
Secondary outcomes
1
Description
Age
Timepoint
Between 2 and 14 days of old age
Method of measurement
Since birthday
2
Description
Duration of hospitalization
Timepoint
24,48 and 72 hours after phototherapy
Method of measurement
days
3
Description
Sex
Timepoint
Beginning of study
Method of measurement
Physical examination
4
Description
Blood group
Timepoint
Beginning of study
Method of measurement
Laboratory test
Intervention groups
1
Description
One hundred fifty neonates with hyperbilirubinemia who were admitted at neonatal ward of Besat hospital of Hamedan, Iran and who are breast-fed were divided to two groups. seventy five neonates in intervention groupreceived Bilineaster 5 drops per kg of body weight three times a day in addition to the phototherapy
Category
Treatment - Drugs
2
Description
One hundred fifty neonates with hyperbilirubinemia who were admitted at neonatal ward of Besat hospital of Hamedan, Iran and who are breast-fed were divided to two groups. seventy five neonates in control group received phototherapy alone
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Dr. Fatemeh Eghbalian
Street address
Neonatal ward, Besat Hospital, Fatemieh Ave.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University Of Medical Sciences
Full name of responsible person
Dr. Fatemeh Eghbalian
Street address
Fatemieh ave,Besat Hospital,Hamedan,Iran
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamedan University of medical science
Full name of responsible person
Dr. Fatemeh Eghbalian
Position
Professor
Other areas of specialty/work
Street address
Hamedan, Fatemieh ave.
City
Hamedan
Postal code
6516837634
Phone
+98 81 1264 0081
Fax
Email
eghbalian@umsha.ac.ireghbalian_fa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan university of medical science
Full name of responsible person
Dr.Fatemeh Eghbalian
Position
Professor
Other areas of specialty/work
Street address
Hamedan, Fatemieh ave.
City
Hamedan
Postal code
Phone
+98 81 1264 0081
Fax
Email
eghbalian@umsha.ac.ireghbalian_fa@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)