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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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History
# Registration date Revision Id
5 2018-09-28, 1397/07/06 88523
4 2018-06-25, 1397/04/04 56848
3 2018-05-09, 1397/02/19 45515
2 2016-10-22, 1395/08/01 22922
1
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Changes made to previous revision
This is the first revision

Protocol summary

Summary
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. 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. Randomization: using blocking method. 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. 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. After administration of Manna of Cotoneaster, all neonates are examined by neonatal specialist. 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

Acronym
IRCT registration information
IRCT registration number: IRCT2016060128188N1
Registration date: 2016-10-22, 1395/08/01
Registration timing: prospective

Last update:
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: 1) term infant (with gestational age 38-42 weeks); 2) birth weight 2.5-4 kg; 3) no postpartum complications; 4) breastfeeding within the hour of birth; 5) availability of parents for follow-up purposes; 6) PO tolerance by infant (no nausea, vomiting or obstructive symptoms); 7) no meconium staining; 8) no need for CPR at birth; and 9) no labor trauma Exclusion criteria: 1) genetic and congenital abnormalities or intrauterine infections; 2) jaundice within the first 24 hours of birth; 3) ABO or Rh incompatibility; 4) presence of neonatal hemolytic process; 5) neonates with bleeding and cephalohematoma; and 6) self-administration of Cotoneaster
Age
From 1 year old to 14 years 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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using blocking method

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

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
Postal code
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: Laboratory test

Secondary outcomes

1

Description
Require hospitalization and Length of hospitalization days
Timepoint
At the time of discharge
Method of measurement
From the time of admission to discharge

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
City
Sari

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. Enayati
Street address
Sari ,Moalem square
City
Sari
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
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
Mazandaran Medical Sciences University
Full name of responsible person
Dr. Azadbakht
Position
Ph.D of Farmacognosy
Other areas of specialty/work
Street address
Pharmacology Faculty of Maazndaran Medical Sciences University
City
Sari
Postal code
Phone
+98 11 3354 3728
Fax
Email
azadbakht110@gmail.commazadbakht@mazums.ac.ir
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
Other areas of specialty/work
Street address
Sari Imam khomeini Hospital
City
Sari
Postal code
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
Other areas of specialty/work
Street address
Sari,
City
Sari,complementry and Taditional Medicine Center and
Postal code
Iran
Phone
+98 11 3324 4893
Fax
Email
mmfir@yahoo.comm.fakhri@mazums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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