The effects of adding either Clofibrate or Phenobarbital on bilirubin level hospitalization and phototherapy period are evaluated in icteric non-hemolytic newborns. Iinclusion criteria: icteric non-hemolytic; term neonates; indirect icter; breast feeding only. Exclusion criteria: Infants with hemolytic icter; premature neonates; direct icter; formula feeding.
90 neonates admitted at Hajar hospital; Shahrekord, at the year 2012 will be included in the study. They will be divided in three groups each with 30 neonates. Two groups receive 100 mg /kg Clofibrate or 5 mg /kg Phenobarbital orally as single dose on arrival, in addition to phototerapy. The control group receives phototherapy only. Serum bilirubin level is measured at reception and 12, 24, 48 and 72 hours after beginning of drug therapy. These values together with hospitalization and phototherapy period are compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202199073N1
Registration date:2012-07-05, 1391/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Majid Hamidi
Name of organization / entity
Shahrekord University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
mhamidi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellery for Research, Shahrekord university of medical science, Iran
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of clofibrate and Phenobarbital on bilirubin level, hospitalization and phototherapy period in icteric non hemolytic newborns
Public title
Evaluating the effect of drug therapy on neonatal icter
Purpose
Treatment
Inclusion/Exclusion criteria
Iinclusion criteria:Parents permission; Infants with non-hemolytic icter; term neonates (37-42 weeks age); birth weight 2/5- 4kg; breast feeding only; indirect bilirubin level between 15-20 mg/dl on arrival; jaundice beginning at days 3-11 after birth; hematocrit level less than 65% or Hb under 20
Exclusion criteria: physical anomalies; previous remedy consumption; previous history of jaundice therapy; sepsis
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Science
Street address
Office of Medical Science, kashani street
City
Shahrekord
Postal code
8813833435
Approval date
2008-06-22, 1387/04/02
Ethics committee reference number
2-4-87
Health conditions studied
1
Description of health condition studied
Icteric non-hemolitic newborns
ICD-10 code
p59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Serum bilirubin level
Timepoint
On arival and 12, 24, 48 and 72 hours after
Method of measurement
mg/dl
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
Day
Method of measurement
Days beeing hospitalized
Intervention groups
1
Description
Group1: prescribed 100 mg /kg clofibrate orally as single dose on arrival, in addition to phototerapy for 3 days.
Category
Treatment - Drugs
2
Description
Group 2: prescribed 5 mg /kg phenobarbital orally as single dose on arrival, in addition to phototerapy for 3 days.
Category
Treatment - Drugs
3
Description
Group 3: only reseaved distrilled water in addition to phototherapy for 3 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Hajar Hospital
Full name of responsible person
Dr. Hamidi
Street address
Hajar hospital, Varzesh Street,Shahrekord,IRAN
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Science
Full name of responsible person
Vice Chancellery for Research, Dr. M Mobasheri
Street address
Vice Chancellery for Research, Shahrekord University of Medical Science, Kashani street, Shahrekord ,Iran
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Science
Full name of responsible person
Dr. Majid Hamidi
Position
Academic member
Other areas of specialty/work
Street address
Hajar hospital, Varzesh street, Shahrekord,Iran
City
Shahrekord
Postal code
Phone
+381 22 20016
Fax
Email
majid_hamidi48@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pediatrics, Shahrekord University of Medical Sciense,
Full name of responsible person
Dr. Majid Hamidi
Position
Neonatologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciense, Rahmatiye Avenu,Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+381 33 30061
Fax
Email
skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciense
Full name of responsible person
Dr. Majid Hamidi
Position
Academic Member
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciense, Rahmatiye Avenue, Shahrekord,Iran
City
Shahrekord
Postal code
Phone
+381 33 30061
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)