Purpose: Evaluation of oral fenofibrate on serum bilirubin level in term neonates with hyperbilirubinemia all the newborns with an age of more than 72 hours that had been refered to Amirkola Children's Hospital (ACH) with serum bilirubin level more than 15 mg/dl have been considered as the case group and receive phototherapy according to the ACH phototherapy protocol, on the other hand newborn with serum bilirubin level more than 15 mg/dl have been considered as control group in both groups phototherapy were done according to the ACH phototherapy protocol bilirubin was cheked by diazo (photometr) method by darman farazkave kits company, Iran.
If we considered the impact factor 0.6 for during of admission and 60 percent ability test, the sample size was calculated for each group 40 neonates. The study is double blinded and performed via a random number table. Study phases are as clinical research and done in one center. The intervention group receive 10 mg/dl fenofibrate, but the control group receive nothing, other than phototherapy. Inclusion criteria: full term newborns with an age of more than 72 hours and serum bilirubin level more than 15 mg/dl. Exclusion criteria: preterm neonates, IUGR, sepsis, respiratory distress. Intervention: fenofibrate administration. Primary outcome: determination of serum bilirubin level. The secondary outcome: duration of phototherapy, unresponsive to phototherapy, severe hyperbilirubinemia and need to exchange in two groups.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017081635732N1
Registration date:2017-10-17, 1396/07/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
maryam vafaeinezhad
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
m.vafaeinezhad@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol university of medical sciences
Expected recruitment start date
2017-09-22, 1396/06/31
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral fenofibrate on serum bilirubin level in term neonates with hyperbilirubinemia.
Public title
Effect of oral fenofibrate on serum bilirubin level in term neonates with hyperbilirubinemia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: full-term newborns, with of age of more than 72 hour and serum bilirubin level more than 15 mg/dl.
Exclusion criteria: Preterm infants, IUGR, Congenital anomaly, Respiratory distress, sepsis.
Age
From 1 day old to 28 days old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Non-Communicable Pediatric Diseases Research Center, No 19, Amirkola Children’s Hospital, Amirkola,
City
Babol
Postal code
47317-41151
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
MUBABOL.HRI.REC.1396.36
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Serum bilirubin's level
Timepoint
Total serum bilirubin level measured at the time of admission, daily during the hospitalization and at the time of the discharge.
Method of measurement
Bilirubin was checked by diazo (Photometr) method by farazkave therapy kits that producing in Iran.
Secondary outcomes
1
Description
Duration phototherapy unresponsive to phototherapy, severe hyperbilirubinemia need to exchange.
Timepoint
Time of admission and time of discharge
Method of measurement
Auto analyzer
Intervention groups
1
Description
Intervention group: The intervention group receive Fenofibrate 10mg/kg.
Category
Treatment - Drugs
2
Description
control group: The control group receive placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children’s Hospital
Full name of responsible person
Maryam Vafaeinezhad
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, Iran
City
Amirkola, Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences
Full name of responsible person
Dr Ali Akbar Moghaddamnia
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran
City
Babol
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor for Research Technology Affairs, Babol 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
Amirkola Children’s Hospital
Full name of responsible person
Dr Maryam Vafaeinezhad
Position
Pediatrician
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, Iran
City
Amirkola, Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 981132346963
Email
vafaeinezhad.maryam@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Amirkola Children’s Hospital
Full name of responsible person
Dr Mousa Ahmadpour-Kacho
Position
Neonatologist
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province
City
Amirkola, Babol
Postal code
47317-41151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
mousa_ahmadpour@hotmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Amirkola Children’s Hospital
Full name of responsible person
Dr Maryam vafaeinezhad
Position
Pediatrician
Other areas of specialty/work
Street address
No 19, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province
City
Amirkola, Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 981132346963
Email
vafaeinezhad.maryam@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)