The present study aims to assess the therapeutic effect of the Bilinaster drop on jaundice in infants undergoing photo therapy. The study population consists of all infants with jaundice. The present randomized double-blind clinical trial is conducted on two groups of infants; Group 1: The infant with jaundice receive placebo. Group 2: The infant with jaundice receive Bilinaster drop. The sample size is determined using mean difference formula as 100 infants in each group, making a total sample size of 200 infants. Conduct and randomization: Bilinaster and placebo drops (medication and placebo) are produced by Sobhan Pharmaceutical Company in similar bottles and packing. placebo contains the same product like bilineaster but without manna. 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. Infants 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. This study is done after parents consent. Inclusion criteria include all infants present with jaundice. Exclusion criteria include being 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:IRCT2016091828188N3
Registration date:2017-06-13, 1396/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-06-13, 1396/03/23
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
2017-04-21, 1396/02/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Bilinaster drop in management of neonatal hyperbilirubinemia: a clinical trial
Public title
The investigation of theraputic effect of Bilinaster drop on neonatal hyperbiirubinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: All infants who present with jaundice with weight between 2500 -4000 gr. 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:
100
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
2017-02-28, 1395/12/10
Ethics committee reference number
IR.MAZUMS.REC.95.2647
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Baby serum total bilirubin
Timepoint
Every 24 hours for 5 days
Method of measurement
Laboratory test
2
Description
The frequency of defecation
Timepoint
Daily
Method of measurement
Examination
Secondary outcomes
1
Description
Length of hospitalization days
Timepoint
At the time of discharge
Method of measurement
From the time of admission to discharge
2
Description
The incidence of complications arising from the use of Cotoneaster
Timepoint
Every 24 hours for 5 days
Method of measurement
Observation and complete check list
3
Description
Evaluation of side effects in case of Cotoneaster
Timepoint
Every 24 hours for 5 days
Method of measurement
Observation and complete check list
Intervention groups
1
Description
Control group: The infant with jaundice will receive placebo. The infants will receive 5 drops of placebo per kg, every 8 hours for 5 days.
Category
Placebo
2
Description
Intervention Group 1: The infant with jaundice will receive Bilinaster drop. Infants will receive 5 drops of Bilinaster per kg every 8 hours for 5 days.