Investigation the effect of oral agar gel on reduction of non-hemolytic jaundice intensity in term neonates
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 140 neonates with
non-hemolytic jaundice.
Settings and conduct
This study will be conducted with the aim of investigation the effect of oral agar gel on reduction of non-hemolytic jaundice intensity in 140 term neonates. After inclusion in the study, using block randomization method with blocks of ten, the neonates will be assigned into two groups; intervention group receiving 500 mg agar in 2.5 cc of distilled water every 6 hours for 3 days and control group receiving only 2.5 cc of distilled water every 6 hours for 3 days. The neonates will be brought to pediatric clinic daily for 3 days and their jaundice will be measured by bili-check set and compared together in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being term; Breastfeeding; Birth weight more than 3000 grams; Having jaundice
Exclusion criteria: Neonatal sepsis; Hemolytic jaundice
Intervention groups
Intervention group: Receiving 500 mg agar in 2.5 cc of distilled water every 6 hours for 3 days
Control group: Receiving only 2.5 cc of distilled water every 6 hours for 3 days
Main outcome variables
Jaundice intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180724040580N1
Registration date:2018-08-20, 1397/05/29
Registration timing:registered_while_recruiting
Last update:2018-08-20, 1397/05/29
Update count:0
Registration date
2018-08-20, 1397/05/29
Registrant information
Name
Bahram Lael Roodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 1000
Email address
b.laelroodi@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral agar gel on reduction of non-hemolytic jaundice intensity in term neonates
Public title
Effect of agar gel in jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being term
Breastfeeding
Birth weight more than 3000 grams
Having jaundice
Exclusion criteria:
Neonatal sepsis
Hemolytic jaundice
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of ten.
Considering the sample size of 140, 14 blocks with 10 cards (5 cards for each group) will be selected; by selecting each block, 5 patients will be assigned into each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo will be coded as A and B and will be similar in shape so the patient and the caregiver (patient's physician) will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Asadabadi Ave, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
Ir.medsab.rec.1397.022
Health conditions studied
1
Description of health condition studied
Jaundice
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Jaundice intensity
Timepoint
Daily
Method of measurement
Using Bili-Check set
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving 500 mg agar in 2.5 cc of distilled water every 6 hours for 3 days
Category
Treatment - Drugs
2
Description
Control group: Receiving only 2.5 cc of distilled water every 6 hours for 3 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatie Hospital
Full name of responsible person
Bahram Lael Roodi
Street address
Heshmatie Hospital, Asad Abadi street, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1702
Email
b.laelroodi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Ghorat
Street address
Vice chancellor for research, Sabzevar University of Medical Sciences, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4444 6070
Email
drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Bahram Lael Roodi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Asadabadi Ave, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4444 6070
Email
b.laelroodi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Bahram Lael Roodi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Asadabadi Ave, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4444 6070
Email
b.laelroodi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Bahram Lael Roodi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Asadabadi Ave, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4444 6070
Email
b.laelroodi@gmail.com
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
Not applicable
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