Objectives:
To determine the effect of different doses of phenobarbital on total serum bilirubin and duration of hospitalization of neonate with indirect hyperbilirubinemia treated with phototherapy.
Design: Randomized controlled clinical trial
Setting and conduct:
The term neonate with indirect hyperbilirubinemia and indication for phototherapy were randomized into three groups and treated with different doses of phenobarbital. Duration of hospitalization and total serum bilirubin levels was measured at the beginning, 24 and 48 hours after the initiation of treatment.
Participants including major eligibility criteria:
Inclusion criteria:
Term neonate; Weight >= 2500 g; Indirect hyperbilirubinemia; Indication for phototherapy
Exclusion criteria:
Hemolysis from any cause; Blood transfusions; Any previous traditional drug therapy or phototherapy
Sample size:
90 term neonate
Intervention:
Group I- 10 mg/kg loading dose of phenobarbital on first day followed by 5 mg/kg/day till discharge plus phototherapy (n=30); Group II- 3.5 mg/day phenobarbital from day 1 till discharge plus phototherapy (n=30); Group III- Phototherapy.
Main outcome measures (variables):
Total serum bilirubin levels; Duration of hospitalization
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052628090N1
Registration date:2016-08-06, 1395/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-06, 1395/05/16
Registrant information
Name
Nafiseh Ataie
Name of organization / entity
Qazvin University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8709
Email address
n.ataie@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Science
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Phenobarbital in various doses on the duration of hospitalization in non-hemolytic neonatal jaundice under phototherapy
Public title
The effect of Phenobarbital on the duration of hospitalization in non-hemolytic neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term neonate (> 37 weeks); Weight >= 2500 g; Indirect hyperbilirubinemia (Total bilirubin level: 17-20 mg/dL); Indication for phototherapy
Exclusion criteria:
Hemolysis from any cause; Metabolic and endocrine disorders; Genetic or chromosomal disorders; Sepsis; Blood transfusions; Any previous traditional drug therapy or phototherapy ; Vitamin K deficiency or bleeding in newborns; History of taking vitamin K by the mother during pregnancy; Discharge of infants with personal consent of parents before completion of treatment; Lack of parental consent for treatment or study
Age
From 3 days old to 5 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Qazvin university of Medical Science
Street address
Qazvin University Of Medical Sciences, Shahid Bahonar Blvd., Deputy for Research and Technology
City
Qazvin
Postal code
Approval date
2015-09-30, 1394/07/08
Ethics committee reference number
IR.QUMS.REC.1394.140
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
Total serum bilirubin levels
Timepoint
before, 24 and 48 hours after the initiation of treatment
Method of measurement
Blood test
2
Description
Duration of hospitalization
Timepoint
Discharge time
Method of measurement
Patient file
Secondary outcomes
empty
Intervention groups
1
Description
Case group I: In addition to phototherapy, 10 mg/kg loading dose of phenobarbital was prescribed on first day followed by 5 mg/kg/day until the treatment of jaundice plus phototherapy.
Category
Treatment - Drugs
2
Description
Case group II: In addition to phototherapy, 3.5 mg/day phenobarbital was prescribedfrom day 1 until the treatment of jaundice plus phototherapy.
Category
Treatment - Drugs
3
Description
Control Group: Until the treatment of jaundice, Just received phototherapy.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Nafiseh Ataei
Street address
Qods Hospital, East Palestine St.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Taghi Naserpour, Vice chancellor for research, Qazvin University of Medical Sciences
Street address
Qazvin University Of Medical Sciences, Shahid Bahonar Blvd., Deputy for Research and Technology, Qazvin, Iran
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Science
Full name of responsible person
Nafiseh Ataie
Position
Pediatric residents
Other areas of specialty/work
Street address
Qods Hospital, East Palestine St.
City
Qazvin
Postal code
Phone
+98 28 3333 4807
Fax
Email
dr.nafiseh.ataie@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical science
Full name of responsible person
Manoochehr Mahram
Position
Pediatricians
Other areas of specialty/work
Street address
Qods hospital, East Palestine St.
City
Qazvin
Postal code
Phone
+98 28 3333 4807
Fax
Email
drmahram@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Nafiseh Ataie
Position
Pediatric residents
Other areas of specialty/work
Street address
Qods Hospital, East Palestine St.
City
Qazvin
Postal code
Phone
+98 283333480700
Fax
Email
dr.nafiseh.ataie@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)