Protocol summary
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Study aim
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therapeutic effect of the researcher-made cotoneaster drop on jaundice in infants undergoing phototherapy.
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Design
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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. 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 Sari Faculty of Pharmacology laboratory in similar bottles and packing. A computer software program is used to produce random numbers to allocate the medication and placebo to four groups.
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Settings and conduct
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Sari, Bu Alisina Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include all breastfed term neonate 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.
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Intervention groups
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Intervention group 1(Control): The neonate with jaundice and mother will receive a placebo.
Intervention group 2: The neonate with jaundice and the mother both will receive cotoneaster drops
Intervention group 3: The neonate with jaundice will receive cotoneaster drops and the mother will receive placebo.
Intervention group 4: The neonate with jaundice will receive a placebo, and the mother will receive cotoneaster drops.
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Main outcome variables
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Baby serum total bilirubin, The incidence of complications arising from the use of Cotoneaster
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016060428188N2
Registration date:
2016-12-26, 1395/10/06
Registration timing:
registered_while_recruiting
Last update:
2019-04-24, 1398/02/04
Update count:
1
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Registration date
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2016-12-26, 1395/10/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for research of Mazandaran University of Medical Sciences
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Expected recruitment start date
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2016-10-22, 1395/08/01
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Expected recruitment end date
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2018-01-05, 1396/10/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Assessment of the effect of Cotoneaster drops in management of neonatal hyperbilirubinemia: a clinical trial
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Public title
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The investigation of theraputic effect of Cotoneaster drops on neonatal hyperbiirubinemia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
All term neonate who present with jaundice, whose weights are 2500 to 4000 gr and who are feeding with breast milk
The neonate 1 to 14 days old
Exclusion criteria:
blood incompatibility; Rh incompatibility; Fauvism; immaturity; need for blood transfusions; infection; hemolysis.
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Age
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From 1 day old to 14 days old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
200
More than 1 sample in each individual
Number of samples in each individual:
3
Measuring Bilirubin
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A computer software program is used to produce random numbers to allocate the medication and placebo to four groups
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Group 1: The neonate with jaundice and the mother receive placebo. Group 2: The neonate with jaundice and the mother receive cotoneaster drops. Group 3: The neonate with jaundice receives cotoneaster drops and the mother receives placebo. Group 4: The infant with jaundice receives placebo and the mother receives cotoneaster drops.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Using blocking method
Ethics committees
1
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Ethics committee
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Approval date
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2015-04-08, 1394/01/19
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Ethics committee reference number
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IR.MAZUMS.REC.1394.1316
Health conditions studied
1
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Description of health condition studied
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Neonatal jaundice
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ICD-10 code
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P59.9
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ICD-10 code description
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Neonatal jaundice, unspecified
Primary outcomes
1
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Description
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Baby serum total bilirubin
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Timepoint
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Every 24 hours for 5 days
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Method of measurement
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Laboratory test
Secondary outcomes
1
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Description
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Length of hospitalisation days
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Timepoint
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At the time of discharge
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Method of measurement
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From the time of admission to discharge
2
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Description
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Added at 2017-06-11: The incidence of complications arising from the use of Cotoneaster
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Timepoint
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Added at 2017-06-11: Every 24 hours for 5 days
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Method of measurement
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Added at 2017-06-11: Observation and complete check list
3
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Description
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Added at 2017-06-11: Evaluation of side effects in case of Cotoneaster
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Timepoint
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Added at 2017-06-11: Every 24 hours for 5 days
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Method of measurement
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Added at 2017-06-11: Observation and complete check list
Intervention groups
1
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Description
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Intervention group 1 (Control): The neonate with jaundice and mother will receive placebo. The neonate with jaundice will receive placebo drops per day is similar to the number of cotoneaster drops. The mother will receive number of placebo drops per day is similar to the number of cotoneaster drops
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: The neonate with jaundice and the mother both will receive cotoneaster drops. Mothers will receive 5 ml of cotoneaster drops every 8 hours for 5 days. Neonate will receive amount of 1 g of cotoneaster per day is divided into 3 doses until 5 days.
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Category
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Treatment - Drugs
3
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Description
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Intervention group 3: The neonate with jaundice will receive cotoneaster drops and the mother will receive placebo. The mother will receive number of placebo drops per day is similar to the number of cotoneaster drops. Neonate will receive amount of 1 g of cotoneaster per day is divided into 3 doses until 5 days.
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Category
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Treatment - Drugs
4
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Description
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Intervention group 4: The neonate with jaundice will receive placebo, and the mother will receive cotoneaster drops. The neonate will receive number of placebo drops per day is similar to the number of cotoneaster drops. Mothers will receive 5 ml of cotoneaster drops every 8 hours for 5 days.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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-
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Grant code / Reference number
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1394.1316
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Data is available as an article as soon as the article is published with permission from the corresponding author.
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To whom data/document is available
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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.
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Under which criteria data/document could be used
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The article's data is available in case of publication and is obtained by permission from the corresponding author.
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From where data/document is obtainable
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The data is available to the journal and is accessible by obtaining permission from the corresponding author.
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What processes are involved for a request to access data/document
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Data is available from the journal after publication of the article.
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Comments
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