Investigating the effect of fenofibrate on prevention of neonatal hyperbilirubinemia in mothers with O type blood group
Design
A randomized single-blind study with two groups of 60 neonatal (120 neonatal in total) in fenofibrate and control groups. Random number table was used for randomization.
Settings and conduct
The study is a clinical trial and is performed in two centers of Shahid Yahya Nejad and Amirkola Children's Hospital. A cord blood sample is taken from the neonate and the neonate is included in the study if he or she has blood type A or B. The neonatal are then randomly divided into two groups of 60 people. After getting consent from parents and after breastfeeding in the first hour, the content of fenofibrate capsules is given to the case group, at a dose of 10 mg per kg as a single dose, orally and in solution distilled water. Bilirubin levels will be measured using a dermal bilirubin meter at 12, 24, 48 and 72 hours after birth for both groups. The study is single blind and is done through tables of random numbers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Term neonatal (37 weeks to 41 weeks and 6 days), born with blood type A or B from mothers with O blood type, and fathers with A, B or AB blood type, without congenital anomalies and birth trauma and also resuscitation at birth, born by elective cesarean section that did not receive induction before delivery, and without Rh incompatibility; Output criteria: neonatal using other medicines such as: phenobarbital, outpatient medicines, etc., neonatal with G6PD enzyme.
Intervention groups
Intervention group: Fenofibrate is given 10 mg per kg in a single dose.
Control group: no medicine is given.
Main outcome variables
Transcutaneous bilirubin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200822048473N1
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Seddighe norouzian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 0538
Email address
yazdi.mohammad@nit.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-24, 1399/06/03
Expected recruitment end date
2021-08-25, 1400/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fenofibrate on the prevention of neonatal hyperbilirubinemia in mothers with O type blood group
Public title
The effect of fenofibrate on the prevention of neonatal hyperbilirubinemia in mothers with O type blood group
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Term neonatal (37 weeks to 41 weeks and 6 days)
Neonatal with blood type A or B from mothers with positive O blood type and fathers with A, B or AB blood types
Without congenital anomalies, birth trauma and history of resuscitation at birth
Neonatal born by elective cesarean section who did not receive induction before delivery
Rh incompatibility
Exclusion criteria:
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, by simple randomization method and using table of random numbers, 120 patients are divided into two study groups and receive the intervention of the corresponding group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The sampler and the researcher, as the person prescribing the medicine, are aware of the study process, but the neonate is not aware of the study process.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-08-10, 1399/05/20
Ethics committee reference number
IR.MUBABOL.REC.1399.229
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P58
ICD-10 code description
Neonatal jaundice due to other excessive hemolysis
Primary outcomes
1
Description
Transcutaneous bilirubin level
Timepoint
Measurement of transcutaneous bilirubin levels at the end of 12, 24, 48 and 72 hours after birth and at the time of admission, in both control and fenofibrate groups
Method of measurement
Transcutaneous bilirubin meter
Secondary outcomes
1
Description
Jaundice leading to hospitalization
Timepoint
During hospitalization
Method of measurement
Blood test
2
Description
Duration of phototherapy
Timepoint
During hospitalization
Method of measurement
Duration in days
3
Description
The rate of severe jaundice
Timepoint
During hospitalization
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Fenofibrate is given as a single dose of 10 mg per kg.