To assess the effect of phototherapy with and without probiotics on serum bilirubin level in term infants
Design
This is a single-blind randomized clinical trial, phase II, in which 150 eligible infants will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible infants with neonatal jaundice who will refer to Besat Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single so that neonates will not be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 1 to 28 days,
Healthy infant,
Birth weight above 2500 g
Exclusion criteria:
Fetal age less than 37 weeks,
Immunocompatibility of blood groups,
Immunocompatibility of Rh,
Glucose 6 phosphate dehydrogenase deficiency,
First-day jaundice.
Taking phenobarbital during pregnancy by the mother
Intervention groups
Intervention group:
Routine phototherapy plus probiotic oral drop (Pedilact) made by Zist-Takhmir Company 10 drops daily for 3 days
Control group:
Just routine phototherapy
Main outcome variables
Primary outcome:
Mean serum bilirubin level of infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N306
Registration date:2019-10-05, 1398/07/13
Registration timing:prospective
Last update:2019-10-05, 1398/07/13
Update count:0
Registration date
2019-10-05, 1398/07/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of phototherapy with and without probiotics on serum bilirubin level in term infants: a single-blind randomized clinical trial
Public title
Effect of phototherapy with and without probiotics on serum bilirubin level in term infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 1 to 28 days,
Healthy infant,
Birth weight above 2500 g
Exclusion criteria:
Fetal age less than 37 weeks,
Immunocompatibility of blood groups,
Immunocompatibility of Rh,
Glucose 6 phosphate dehydrogenase deficiency,
First day jaundice.
Taking phenobarbital during pregnancy by the mother
Age
From 1 day old to 28 days old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Infants will not be aware of the type of intervention. Thus, the trial will be run as single-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.UMSHA.REC.1398.458
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
Mean serum bilirubin level of infants
Timepoint
Before the intervention and 2 and 3 days after the intervention
Method of measurement
By laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine phototherapy plus probiotic oral drop (Pedilact) made by Zist-Takhmir Company 10 drops daily for 3 days
Category
Treatment - Drugs
2
Description
Control group: Just routine phototherapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan City
Full name of responsible person
Soroush Taheri Talesh
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
kopolak4@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Soroush Taheri Talesh
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
kopolak4@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Eghbalian
Position
Podiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
Eghbalian_fa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available