Effect of Phenobarbital to Reduce Newborn Readmissions for Hyperbilirubinemia
Design
Randomised, parallel group trial of 142 patients, and followed for one week
Settings and conduct
Study will conduct on neonates of Izadi Qom Hospital on neonates admitted for jaundice during the first 10 days of birth
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have a major risk factors for development of severe hyperbilirubinemia and hospitalized because of hyperbilirubinemia in the first 10 days of birth. Exclusion criteria: Major congenital malformations, Gestational age <35 weeks and Weight <2500 g at birth.
Intervention groups
Intervention group: Phenobarbital, oral, 3.5 mg/kg/day, for the first 7 days after discharge; Control group: No intervention
Main outcome variables
Rate of readmissions for neonatal jaundice within 7 days after discharge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170215032587N2
Registration date:2018-02-27, 1396/12/08
Registration timing:retrospective
Last update:2018-02-27, 1396/12/08
Update count:0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Mohammad Aghaali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 751 5639
Email address
maghaali@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-09, 1396/07/17
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-10-09, 1396/07/17
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Effect of Phenobarbital to Reduce Newborn Readmissions for Hyperbilirubinemia
Public title
Effect of Phenobarbital Neonatal Ichter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have a major risk factors for development of severe hyperbilirubinemia
Hospitalized because of hyperbilirubinemia in the first 10 days of birth
Exclusion criteria:
Major congenital malformations
Gestational age <35 weeks
Weight <2500 g at birth
History of blood transfusion
History of IVIG administration
History of maternal use of phenobarbital in the last month of pregnancy
Whose parents refused to give consent
Age
From 1 day old to 10 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
142
Actual sample size reached:
142
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization at the level of the individual
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 Qom University of Medical Sciences
Street address
No. 83, Alley 4, Alley 1.1, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2015-03-08, 1393/12/17
Ethics committee reference number
MUQ.REC.1393.138
2
Ethics committee
Approval date
empty
Ethics committee reference number
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
Rate of readmissions for neonatal jaundice
Timepoint
7 days after discharge
Method of measurement
Physician examination
Secondary outcomes
1
Description
Mean serum bilirubin levels
Timepoint
Before intervention and 1, 3, 5, 7 day after intervention
Method of measurement
Blood test
2
Description
Adverse effects of phenobarbital (feed intolerance, lethargy, apnea and cyanotic spells)
Timepoint
During 1 weeks after intervention
Method of measurement
Physician examination
Intervention groups
1
Description
Intervention group: Phenobarbital, oral, 3.5 mg/kg/day, for the first 7 days after discharge
Category
Treatment - Drugs
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Izadi hospital
Full name of responsible person
Parvaneh Sadeghi-moghaddam
Street address
Izadi hospital, Azar Ave, Qom
City
Qom
Province
Ghoum
Postal code
3715888566
Phone
+98 25 3721 1301
Email
Psadeghi@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
No. 83, Alley 4, Alley 1.1, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2720
Email
hsaghafi@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Aghaali
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Qom University of Medical Science, Saheli Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3285 2720
Fax
+98 25 3285 8464
Email
maghaali@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Aghaali
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Qom University of Medical Science, Saheli Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3285 2720
Fax
+98 25 3285 8464
Email
maghaali@muq.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Aghaali
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Qom University of Medical Science, Saheli Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3285 2720
Fax
+98 25 3285 8464
Email
maghaali@muq.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD