Protocol summary
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Study aim
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The present study aims to assess the therapeutic effect of the Bilinaster drop on jaundice in neonates undergoing phototherapy.
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Design
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The present study is a randomized double-blind clinical trial with parallel groups using the blocking method.
The sample size is determined using the mean difference formula as 50 infants in each group, making a total sample size of 100 neonates.
A computer software program is used to produce random numbers to allocate the medication and placebo to two groups.
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Settings and conduct
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The study setting will be in Bu Alisina Hospital in Sari. Adequate medication and placebo for each group 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 will enter the present study according to inclusion criteria and receive their particular medications.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: All term neonate with jaundice weighted between 2500 -4000 gr and fed with breast milk. Exclusion criteria include babies with the incompatibility of blood groups or RH, suffering from fauvism, being preterm, needing blood transfusion, hemolysis or infection
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Intervention groups
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Control group: The neonate with jaundice will receive placebo. The number of placebo drops per day is similar to the number of bilinaster drops.
Intervention Group: The neonate with jaundice will receive Bilineaster drop which is manufactured by Sobhan Daru Company and is included manna of cotoneaster ( Shire-khesht). Bilineaster drop is prescribed about 1 g manna per day (15 drop) that is divided into 3 doses and at most until 5 days .
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Main outcome variables
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Baby serum total bilirubin
General information
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Reason for update
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Complete the information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016091828188N3
Registration date:
2017-06-13, 1396/03/23
Registration timing:
registered_while_recruiting
Last update:
2020-05-03, 1399/02/14
Update count:
1
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Registration date
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2017-06-13, 1396/03/23
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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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2017-03-21, 1396/01/01
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Expected recruitment end date
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2017-10-23, 1396/08/01
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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 Bilinaster drop in the management of neonatal hyperbilirubinemia
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Public title
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The investigation of theraputic effect of Bilinaster drop 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 with jaundice weighted between 2500 -4000 gr and fed with breast milk
Exclusion criteria:
blood incompatibility or Rh incompatibility
Fauvism
immaturity
need for blood transfusions
hemolysis
infection
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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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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
100
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 two groups. Adequate medication and placebo for each group 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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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For blinding in this trial, similarity of interventions in the two treatment groups under study was anticipated. The placebo was prepared in similar packages, with all the same physical and similar properties (in terms of color, odor, consistency, etc.). The amount of ingestion and the number of times a day was the same in both products. The only difference in these two products was the code inserted (numerical code) on the package and the corresponding box. As the mothers and prescriber (nurse) and laboratory technician were not aware of the nature of these two products and the codes entered.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2017-02-28, 1395/12/10
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Ethics committee reference number
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IR.MAZUMS.REC.1395.2647
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 hospitalization 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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The incidence of complications arising from the use of Cotoneaster
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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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Observation and complete check list
3
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Description
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Evaluation of side effects in case of Cotoneaster
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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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Observation and complete check list
4
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Description
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The frequency of defecation
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Timepoint
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Daily
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Method of measurement
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Examination
Intervention groups
1
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Description
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Control group: The neonate with jaundice will receive placebo. The number of placebo drops per day is similar to the number of bilinaster drops.
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Category
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Placebo
2
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Description
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Intervention group: The neonate with jaundice will receive Bilineaster drop which is manufactured by Sobhan Daru Company and is included manna of cotoneaster ( Shire-khesht). Bilineaster drop is prescribed about 1 g manna per day (15 drop) that is divided into 3 doses and at most until 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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Grant code / Reference number
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1395.2647
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available