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Comparison of the Effect of vitamin E Supplementation on the Treatment of Neonates with Hyperbilirubinemia: A Double-blind Randomized Clinical Trial

Protocol summary

Study aim
Determining the effect of vitamin E supplementation on the treatment of newborns with hyperbilirubinemia
Design
This controlled, parallel-group, double-blind, randomized, phase 3 clinical trial is conducted on 70 infants. Randomization of infants into drug and placebo groups was done using the Random between function of Excel software.
Settings and conduct
The study is conducted in the Neonatal Department of Besat Hospital located in Sanandaj, Kurdistan, Iran. In this study, 70 babies are randomly placed in two groups receiving vitamin E and dextrose. Nurses and parents of infants are blinded to the type of drug received. In order to perform blinding, the drugs are kept in dark and same-colored bottles labeled A and B and given to babies using a dropper.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Term newborns with hyperbilirubinemia admitted to the neonatal department of Besat Hospital of Sanandaj in 2022, gestational age from 37 weeks to 42 weeks and 6 days, birth weight from 2500 gr to 4000 gr Exclusion criteria: Evidence of infection, congenital malformation, history of phenobarbital use, hypothyroidism, intrauterine growth restriction, oral intolerance, mechanical ventilation
Intervention groups
The group receiving vitamin E oral drops at the rate of 0.5 cc once a day. Placebo group: the group receiving 10% dextrose serum in the amount of 0.5 cc once a day
Main outcome variables
Average serum total bilirubin Average serum indirect bilirubin The amount of changes in the mean total serum bilirubin before and after the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220806055625N2
Registration date: 2022-12-26, 1401/10/05
Registration timing: registered_while_recruiting

Last update: 2022-12-26, 1401/10/05
Update count: 0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Siros Hemmatpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 7751
Email address
dr.siroshemmatour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-01-30, 1401/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of vitamin E Supplementation on the Treatment of Neonates with Hyperbilirubinemia: A Double-blind Randomized Clinical Trial
Public title
Investigating the effect of vitamin E on the Treatment of Neonatal Hyperbilirubinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term infants with hyperbilirubinemia admitted to the neonatal department of Besat Sanandaj Hospital in 1401 Gestational age from 37 weeks to 42 weeks and 6 days Birth weight from 2500 Grams to 4000 Grams
Exclusion criteria:
Evidence of infection Congenital malformation History of phenobarbital use in mother Hypothyroidism Inappropriate intrauterine growth Oral intolerance Mechanical ventilation
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Neonates will be completely randomly assigned to two groups receiving vitamin E and placebo (10% Dextrose serum). To perform randomization, Excel software is used with the Random between command. To carry out this process, a two-digit code is assigned to each of the people entered into the study, and then using the software, these numbers are randomly selected to enter each of the groups. Odd or even numbers will be assigned to one group each.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the design is double-blind; so that the neonates studied in two groups and their families and clinical caregivers are blinded to the intervention and intervention status.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
661776796
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.MUK.REC.1400.326

Health conditions studied

1

Description of health condition studied
Neonatal Hyperbilirubinemia
ICD-10 code
P58
ICD-10 code description
Neonatal jaundice due to other excessive hemolysis

Primary outcomes

1

Description
Mean serum total bilirubin
Timepoint
Serum total bilirubin 24 hours, 48 hours and 72 hours after intervention in two groups
Method of measurement
Taking blood samples from the infants in the study at 24 hours, 48 hours and 72 hours after the intervention by a trained nurse and sending them to the lab

2

Description
Mean serum indirect bilirubin
Timepoint
Serum indirect bilirubin 24 hours, 48 hours and 72 hours after intervention in two groups
Method of measurement
Taking blood samples from the infants in the study at 24 hours, 48 hours and 72 hours after the intervention by a trained nurse and sending them to the lab

3

Description
The amount of changes in the mean serum total bilirubin
Timepoint
Before the intervention and 24, 48 and 72 hours after the intervention
Method of measurement
Comparing the average total serum bilirubin before the intervention and the average total serum bilirubin obtained 24, 48 and 72 hours after the intervention.

Secondary outcomes

1

Description
The average number of hospitalization days of newborns in two groups
Timepoint
Number of hospitalization days 24 hours, 48 hours and 72 hours after intervention in two groups
Method of measurement
Registration the number of hospitalization days of the newborns according to the file by a trained nurse

2

Description
The average hours of receiving phototherapy for newborns in two groups
Timepoint
Number of hours receiving phototherapy 24 hours, 48 hours and 72 hours after intervention in two groups
Method of measurement
Registering data of number of hours receiving phototherapy by a trained nurse

3

Description
Possible complications of vitamin E drug
Timepoint
24 hours, 48 hours and 72 hours after the intervention in two groups
Method of measurement
A booklet containing the desired questions related to possible complications (these complications are selected by reviewing the literature) is provided to the mothers of babies and is followed up by a trained nurse.

Intervention groups

1

Description
Intervention group: 35 infants are placed in the group receiving vitamin E orally with a dose of 0/5 cc (equivalent to 10 drops) orally once a day, on the first, second and third days of the intervention.
Category
Treatment - Drugs

2

Description
Control group: 35 infants are placed in the group receiving 10% dextrose serum orally on the first, second and third days of the intervention. Dextrose serum in the amount of 0/5 cc orally once a day is administered to infants in the control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Sirus Hematpour
Street address
Keshavarz Street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3328 5911
Email
Info@muk.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Abidar street
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3322 9494
Email
Info@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sirous Hematpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NO.10, Pirooz alley, Jamejam Avenue
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3322 9494
Email
Dr.siroshematour@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sirous Hematpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NO.10, Pirooz alley, Jamejam Avenue
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3322 9494
Email
Dr.siroshematour@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sirus Hematpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
NO.10, Pirooz alley, Jamejam Avenue
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3322 9494
Email
Dr.siroshematour@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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