The present study aims to assess the therapeutic effect of the researcher-made cotoneaster drop on jaundice in infants undergoing phototherapy. The study population consists of all infants with jaundice. This study is done after getting parents’ consent. The present randomized double-blind clinical trial is conducted among four groups of infants; Group 1: The infant with jaundice and the mother receive placebo. Group 2: The infant with jaundice and the mother receive cotoneaster drops. Group 3: The infant with jaundice receives cotoneaster drops and the mother receives placebo. Group 4: The infant with jaundice receives placebo and the mother receives cotoneaster drops. The sample size is determined using mean difference formula as 50 infants in each group, making a total sample size of 200 infants. Conduct and randomization: Cotoneaster and placebo drops (medication and placebo) are produced by Sobhan Pharmaceutical Company in similar bottles and packing. A computer software program is used to produce random numbers to allocate the medication and placebo to four groups. Adequate medication and placebo for each group (for both infants and mothers) will be placed in a special envelope marked with patient number and medication code. Thus, patients, doctor and assessor will have no knowledge of the nature of medication or group allocation. Infants and mothers will enter the present study according to inclusion criteria and receive their particular medications. The study setting will be in Bu Alisina Hospital in Sari. Inclusion criteria include all breastfed infants weighing between 2500 and 4000 grams and present with jaundice. Exclusion criteria include having incompatible blood group (RH), suffering from fauvism, being preterm, needing blood transfusion, suffering from infection or being the case of hemolysis.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016060428188N2
Registration date:2016-12-26, 1395/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-12-26, 1395/10/06
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 of Mazandaran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Cotoneaster drops in management of neonatal hyperbilirubinemia: a clinical trial
Public title
The investigation of theraputic effect of Cotoneaster drops on neonatal hyperbiirubinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All infants who present with jaundice, whose weights are 2500 to 4000 gr and who are feeding with breast milk. Exclusion criteria; blood incompatibility; Rh incompatibility; Fauvism; immaturity; need for blood transfusions; infection; hemolysis.
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:
200
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moalem square, Sari, Mazandaran
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
Baby serum total bilirubin
Timepoint
Every 24 hours for 5 days
Method of measurement
Laboratory test
Secondary outcomes
1
Description
Length of hospitalisation days
Timepoint
At the time of discharge
Method of measurement
From the time of admission to discharge
2
Description
Added at 2017-06-11: The incidence of complications arising from the use of Cotoneaster
Timepoint
Added at 2017-06-11: Every 24 hours for 5 days
Method of measurement
Added at 2017-06-11: Observation and complete check list
3
Description
Added at 2017-06-11: Evaluation of side effects in case of Cotoneaster
Timepoint
Added at 2017-06-11: Every 24 hours for 5 days
Method of measurement
Added at 2017-06-11: Observation and complete check list
Intervention groups
1
Description
Intervention Group 2: The infant with jaundice will receive cotoneaster drops and the mother will receive placebo. Infants will receive 5 drops of cotoneaster per kg every 8 hours for 5 days. Mothers will receive 5 ml of placebo drops every 8 hours for 5 days.
Category
Treatment - Drugs
2
Description
Intervention Group 3: The infant with jaundice will receive placebo, 5 drops and the mother will receive cotoneaster drops. Infants will receive 5 drops of placebo per kg every 8 hours for 5 days. Mothers will receive 5 ml of cotoneaster drops every 8 hours for 5 days.
Category
Treatment - Drugs
3
Description
Control group: The infant with jaundice and the mother will receive placebo. The infants will receive 5 drops of placebo per kg, every 8 hours for 5 days. Mothers will receive 5 ml of placebo drops every 8 hours for 5 days.
Category
Treatment - Drugs
4
Description
Intervention Group 1: The infant with jaundice and the mother both will receive cotoneaster drops. Infants will receive 5 drops of cotoneaster per kg every 8 hours for 5 days. Mothers will receive 5 ml of cotoneaster drops every 8 hours for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Roya Farhadi
Street address
Imam Khomeini Hospital, Amir Mazandarani Blv, Sari, Iran
City
Sari
2
Recruitment center
Name of recruitment center
Boo Ali Hospital
Full name of responsible person
Roya Farhadi
Street address
Boo Ali Hospital, Pasdaran Blv, Imam Squ, Sari, Mazandaran, Iran
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Vice chancellor for research, Moalem square, Sari
City
Sari
Grant name
-
Grant code / Reference number
941316
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Fharmacy Department, Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Azadbakht
Position
Ph.D of Farmacognosy
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, 18th Km, Khazar Abad Road, Sari
City
Sari
Postal code
Phone
+98 11 3354 3728
Fax
Email
mazadbakht110@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty Of Medicine, Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Neonatal Specialist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Amir Mazandarani Blv, Sari
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
Faculty of Medicine, Mazandaran University of Medical sciences
Full name of responsible person
Moloud Fakhri
Position
Senior lecturer, Ph.D student
Other areas of specialty/work
Street address
Mazandaran University of Medical sciences, 18th Km, Khazar Abad Road, Sari
City
Sari
Postal code
Phone
+98 11 3354 3081
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)