The investigating of prophylactic effect of Manna of Cotoneaster in decreasing of neonatal hyperbilirubinemia :A double blind randomized controlled clinical trial
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General information
7
14
714
Primary outcomes
#1
Added at 2017-06-11: Laboratory test
Added at 2017-06-11: Using a bilirubin test device (if a bilirubin is high, a bilirubin serum test will be performed based on the weight and age curve)
Added at 2017-06-11: LaboratoryUsing a bilirubin test device (if a bilirubin is high, a bilirubin serum test will be performed based on the weight and age curve)
بروزرسانی 1396/3/21: تست آزمايشگاهی
بروزرسانی 1396/3/21: با استفاده از دستگاه بیلی تست (در صورت بالا بودن بیلی روبین بر اساس منحنی وزن وسن آزمایش سرم خون انجام خواهد شد)
بروزرسانی 1396/3/21: با استفاده از دستگاه بیلی تست آزمايشگاهی(در صورت بالا بودن بیلی روبین بر اساس منحنی وزن وسن آزمایش سرم خون انجام خواهد شد)
Secondary outcomes
#1
At the time of discharge
From discharge to 14 days after birth
At the time ofFrom discharge to 14 days after birth
در موقع ترخيص
از زمان ترخيص تا 14 روز پس از تولد
در موقعاز زمان ترخيص تا 14 روز پس از تولد
From the time of admission to discharge
Follow up by phone from the baby's parents
FromFollow up by phone from the time of admission to dischargebaby's parents
از موقع پذيرش تا ترخيص
پیگیری بصورت تلفنی از والدین نوزاد
پیگیری بصورت تلفنی از موقع پذيرش تا ترخيصوالدین نوزاد
Protocol summary
Study aim
The study is a randomized double-blind clinical trial. The purpose of this study is the investigating of prophylactic effect of Manna of Cotoneaster in management of neonatal hyperbilirubinemia. This study was performed on 400 infant's patients, who admitted into neonatal ward in Imam Khomeini hospital, Sari, Iran. Informed consent will be obtained from mothers
Design
Randomization: using blocking method.
Settings and conduct
This study was performed on 400 infant's patients, who admitted into neonatal ward in Imam Khomeini hospital, Sari, Iran. Informed consent will be obtained from mothers.The Blind: To double-blind study, Manna of cotoneaster solution and placebo solution container similar appearance and the user, administer and appraiser of them do not know about it.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All newborns are examined by doctor who not with jaundice and weight is between 2.5 to 4 kg. Exclusion criteria: Babies with a genetic anomaly, Congenital, Intrauterine infection or jaundice within 24 hours of birth and mothers who are not satisfied and want to be excluded
Intervention groups
Groups: in intervention group, Manna of Cotoneaster as oral drops will be given to the neonate 6 hours after birth. In the control group placebo will be administered concurrently with intervention group.
Main outcome variables
Dose of Manna of cotoneaster, which is the daily 3 times to about 1 gram of oral drops, will be given to the baby. The bilirubin concentration measured in 3 sets (24 hours 48 hours and 72 hours after birth) and its number is recorded. The Meconium departure time controlled daily for three days after birth. The baby bilirubin concentration measured through the skin by bilirubin test device. Then on the third day that neonatal follow up examination will be done, bilirubin concentration measured through the skin with the same device.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2016060128188N1
Registration date:2016-10-22, 1395/08/01
Registration timing:prospective
Last update:2018-08-19, 1397/05/28
Update count:3
Registration date
2016-10-22, 1395/08/01
Registrant information
Name
Moloud Fakhri
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7343
Email address
m.fakhri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigating of prophylactic effect of Manna of Cotoneaster in decreasing of neonatal hyperbilirubinemia :A double blind randomized controlled clinical trial
Public title
The investigating of prophylactic effect of Manna of Cotoneaster in neonatal hyperbilirubinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
term infant (with gestational age 38-42 weeks
birth weight 2.5-4 kg
no postpartum complications
breastfeeding within the hour of birth
availability of parents for follow-up purposes
PO tolerance by infant (no nausea, vomiting or obstructive symptoms
no meconium staining
no need for CPR at birth
no labor trauma
Exclusion criteria:
genetic and congenital abnormalities or intrauterine infections
jaundice within the first 24 hours of birth
ABO or Rh incompatibilityABO or Rh incompatibility
presence of neonatal hemolytic process
neonates with bleeding and cephalohematoma
self-administration of Cotoneaster
Age
From 1 day old to 14 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
using blocking method
Blinding (investigator's opinion)
Double blinded
Blinding description
To double-blind study, cotoneaster solution and placebo solution container similar appearance and the user, administer and appraiser of them do not know about it.
Placebo
Used
Assignment
Parallel
Other design features
Using blocking method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran,Sari, Moalem square
City
Sari
Province
Mazandaran
Postal code
4847191971
Approval date
2015-04-08, 1394/01/19
Ethics committee reference number
IR.MAZUMS.REC.941316
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
p59.9
ICD-10 code description
neonatal jaundice
Primary outcomes
1
Description
Added at 2017-06-11: Baby serum total bilirubin
Timepoint
Added at 2017-06-11: Every 24 hours for 3 days
Method of measurement
Added at 2017-06-11: Using a bilirubin test device (if a bilirubin is high, a bilirubin serum test will be performed based on the weight and age curve)
Secondary outcomes
1
Description
Require hospitalization and Length of hospitalization days
Timepoint
From discharge to 14 days after birth
Method of measurement
Follow up by phone from the baby's parents
2
Description
Added at 2017-06-18: Evaluation of side effects in case of Cotoneaster
Timepoint
Added at 2017-06-18: Every 24 hours for 3 days
Method of measurement
Added at 2017-06-18: Observation and complete check list
Intervention groups
1
Description
Intervention group 1: In intervention group, oral drops of cotoneaster, 3 times, each time 15 drops in 3 days will be given to the baby.
Category
Treatment - Drugs
2
Description
Control group: cotoneaster solution and placebo solution container have similar appearance and will be given to the baby, 3 times, each time 15 drops in 3 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Imam Khomeini Hospital
Full name of responsible person
Moloud Fakhri
Street address
َAmir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
۳۳۱۳۱- ۴۸۱۶۶
Phone
+98 11 3336 1700
Email
mmfir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Saiedi
Street address
Sari ,Moalem square
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3448 4800
Email
mmfir@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Mazandaran 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
Mazandaran Medical Sciences University
Full name of responsible person
Dr. Azadbakht
Position
Ph.D of Farmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacology Faculty of Maazndaran Medical Sciences University
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 3728
Fax
Email
azadbakht110@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran Medical Sciences University
Full name of responsible person
Mrs Dr.Farhadi
Position
Neonatal Specialist
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Sari Imam khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3336 1700
Fax
Email
dr_royafarhadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran Medical sciences University
Full name of responsible person
Moloud Fakhri
Position
Senior lecturer, Ph.D student
Latest degree
Master
Other areas of specialty/work
Traditional Medicine
Street address
Sari,
City
Sari,complementry and Taditional Medicine Center and
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3324 4893
Fax
Email
mmfir@yahoo.comm
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information will be published in an article. Details of the data are available at the request of the journal publisher and upon obtaining permission from the corresponding author.
When the data will become available and for how long
Data is available as an article as soon as the article is published with permission from the corresponding author.
To whom data/document is available
The data is provided as an article by the journal, and those who have access to the journal can use the data contained in the article, with the permission of the corresponding author.
Under which criteria data/document could be used
The article's data is available in case of publication and is obtained by permission from the corresponding author.
From where data/document is obtainable
The data is available to the journal and is accessible by obtaining permission from the corresponding author.
What processes are involved for a request to access data/document
Data is available from the journal after publication of the article.