Protocol summary
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Study aim
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Therapeutic effect of jaundice among infants undergoing phototherapy
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Design
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The present randomized double-blind clinical trial is conducted on two groups of infants; Group 1: The infant with jaundice receive placebo. The sample size is determined using mean difference formula as 50 infants in each group, making a total sample size of 100 infants.
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Settings and conduct
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Conduct and randomization: The study setting will be in Bu Ali Hospital in Sari. 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. Bilinoeid and placebo drops (medication and placebo) are provided by the laboratory of Sari Pharmacy Faculty.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: infants present with jaundice
Exclusion criteria: incompatible blood group (RH), fauvism, preterm, needing blood transfusion, suffering from infection or being the case of hemolysis
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Intervention groups
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Control group: The infant with jaundice will receive placebo.
Intervention Group: The infant with jaundice will receive Cotoneaster drop.
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Main outcome variables
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1. Baby serum total bilirubin
2. The frequency of defecation
3. Length of hospitalization days
4. The incidence of complications arising from the use of Cotoneaster
General information
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Reason for update
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Information editing
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160531028188N4
Registration date:
2018-03-05, 1396/12/14
Registration timing:
registered_while_recruiting
Last update:
2020-05-08, 1399/02/19
Update count:
3
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Registration date
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2018-03-05, 1396/12/14
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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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Expected recruitment start date
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2017-09-23, 1396/07/01
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Expected recruitment end date
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2018-08-23, 1397/06/01
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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 Bilinoeid drop on neonatal jaundice
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Public title
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Effect of Bilinoeid drop on neonatal jaundice
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
All infants who present with jaundice with weight between 2500 -4000 gr
Exclusion criteria:
Blood group 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
- Outcome assessor
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Sample size
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Target sample size:
100
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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.
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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. Patients, doctor and assessor will have no knowledge of the nature of medication or group allocation. Bilinoeid and placebo drops (medication and placebo) are provided by the laboratory of Sari Pharmacy Faculty.
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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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2015-04-08, 1394/01/19
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Ethics committee reference number
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IR.Mazums.REC.941316
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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neonatal total bilirubin
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Timepoint
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every 24 hour til 5 days
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Method of measurement
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lab 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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frequency of defecation
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Timepoint
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every 24 hour til 5 days
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Method of measurement
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observation
Intervention groups
1
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Description
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Intervention group: The neonate with jaundice will receives cotoneaster manna drop which is prescribed about 1 g manna per day that is divided into 3 doses (every 8 hour) and at most until 5 days.
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Category
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Treatment - Drugs
2
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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 cotoneaster drops that is divided into 3 doses (every 8 hour) 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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941316
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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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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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available