To evaluate the effects of IVIG in the control of jaundice caused by neonatal hemolytic disease in Motahari Hospital of Urmia
Design
A double-blind randomized clinical trial with a control group, sample of 76 neonates in three equal groups
Settings and conduct
In this double blind randomized clinical trial study, neonates with jaundice in neonatal ward of Motahari hospital of Urmia were divided into three groups. Random allocation was done using randomizer website. Length of stay, duration of phototherapy, need for Plasmapheresis, bilirubin and hemoglobin were evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent of parents, Neonates with Jaundice. Exclusion criteria: Neonates weighing less than 2500 grams
Intervention groups
The first group (prophylaxis group with IVIG 0.5 g / kg within 4 hours), the second group ( treatment group with IVIG 0.5 g / kg within 12 hours) and the third group (control group)
Main outcome variables
Length of stay, duration of phototherapy, need for Plasmapheresis, bilirubin, hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171218037936N3
Registration date:2020-03-07, 1398/12/17
Registration timing:retrospective
Last update:2020-03-07, 1398/12/17
Update count:0
Registration date
2020-03-07, 1398/12/17
Registrant information
Name
Kamran Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3365 4154
Email address
dehghan.k@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-22, 1398/01/02
Expected recruitment end date
2019-09-04, 1398/06/13
Actual recruitment start date
2019-05-01, 1398/02/11
Actual recruitment end date
2019-10-24, 1398/08/02
Trial completion date
2019-10-24, 1398/08/02
Scientific title
The Effect of Intravenous Immunoglobulin on Jaundice Induced by Neonatal Isoimmune Hemolytic Disease
Public title
The Effect of Intravenous Immunoglobulin on Jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with Jaundice
Informed consent of parents
Exclusion criteria:
Neonates weighing less than 2500 grams
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
76
Actual sample size reached:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all eligible patients were assigned to three groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, clinical care giver and statistical analyzer were not aware of groups assigned to neonates.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia, Resalat Boulevard, Emergency alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-04-16, 1398/01/27
Ethics committee reference number
IR.USMU.REC.1398.030
Health conditions studied
1
Description of health condition studied
Jaundice of neonates
ICD-10 code
P58.8
ICD-10 code description
Neonatal jaundice due to other specified excessive hemolysis
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
Once on the time of discharge
Method of measurement
The length of time that the neonate is hospitalized
2
Description
Duration of phototherapy
Timepoint
Once on the time of discharge
Method of measurement
Using a phototherapy machine
3
Description
Plasmapheresis
Timepoint
Once on the time of discharge
Method of measurement
Based on file information
4
Description
Bilirubin
Timepoint
Measured 4 times every 12 hours
Method of measurement
Blood sampling
5
Description
Hemoglobin
Timepoint
Measured 4 times every 12 hours
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The first group (prophylaxis group) included the neonates who received IVIG at dose of 0.5 g / kg within 4 hours. IVIG used in the study had the trade name of Intratect manufactured by Biotest Company of Germany with 5% (50 g/l) solutions, each containing 50 mg immunoglobulin.
Category
Treatment - Drugs
2
Description
Intervention group 2:The second group (treatment group) included the neonates who received 0.5 g/kg of IVIG in the case of uncontrolled and progress of jaundice (hemodialysis) characterized by an increase in bilirubin number despite phototherapy and a decrease in hemoglobin, based on the Bhutani nomogram as approached the blood transfusion number (within the range of 3 gr / dl).
Category
Treatment - Drugs
3
Description
Control group: The third group (control group) included the neonates who received standard phototherapy (Intensive phototherapy). In case of lack of control of jaundice progression in the first and second groups, the second dose of IVIG was injected at the same dose of 0.5 g / kg 12 hours after the previous dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Kamran Dehghan
Street address
Urmia, Resalat Boulevard, Emergency alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
dehghan.k@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Urmia University of Medical Sciences-Resalat Blvd-Emergency Alley. Urmia Vest Azarbaijan Iran, Islamic Republic Of