Effect of oral vitamin A versus control group in the prevention of retinopathy of prematurity in low birth weight neonates: a double-blind randomized clinical trial
To assess the effect of oral vitamin A versus control group in the prevention of retinopathy of prematurity in low birth weight neonates
Design
This is a double-blind randomized clinical trial, phase III, in which 66 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible low birth weight premature neonate referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age less than a month;
Neonate with birth weight less than 1500 g;
Premature neonate with gestational age less than 34 weeks;
Exclusion criteria:
Congenital malformations;
Heart disease or any background disease
Intervention groups
Intervention group:
Routine care including surfactant 5 ml/kg daily and injection of Ampicillin 25 mg/kg every 12 hours and Amikacin 7.5 mg/kg every 12 hours for one week plus oral drop vitamin A 3000 U (manufactured by Hamadan School of Pharmacy) per neonate weight daily for 28 days
Control group:
Just routine care including surfactant 5 ml/kg daily and injection of Ampicillin 25 mg/kg every 12 hours and Amikacin 7.5 mg/kg every 12 hours for one week
Main outcome variables
Primary outcome:
Retinopathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N403
Registration date:2021-08-21, 1400/05/30
Registration timing:prospective
Last update:2021-08-21, 1400/05/30
Update count:0
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral vitamin A versus control group in the prevention of retinopathy of prematurity in low birth weight neonates: a double-blind randomized clinical trial
Public title
Effect of oral vitamin A versus control group in the prevention of retinopathy of prematurity in low birth weight neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than a month;
Neonate with birth weight less than 1500 g;
Premature neonate with gestational age less than 34 weeks;
Exclusion criteria:
Congenital malformations;
Heart disease or any background disease
Age
From 1 day old to 1 month old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on three sheets the name of the intervention and on the other three sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are infants and thus will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-07-10, 1400/04/19
Ethics committee reference number
IR.UMSHA.REC.1400.312
Health conditions studied
1
Description of health condition studied
Retinopathy
ICD-10 code
H35.109
ICD-10 code description
Retinopathy of prematurity, unspecified, unspecified eye
Primary outcomes
1
Description
Retinopathy
Timepoint
Before the intervention and one month later
Method of measurement
Through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care including surfactant 5 ml/kg daily and injection of Ampicillin 25 mg/kg every 12 hours and Amikacin 7.5 mg/kg every 12 hours for one week plus oral drop vitamin A 3000 U (manufactured by Hamadan School of Pharmacy) per neonate weight daily for 28 days
Category
Treatment - Drugs
2
Description
Control group: Just routine care including surfactant 5 ml/kg daily and injection of Ampicillin 25 mg/kg every 12 hours and Amikacin 7.5 mg/kg every 12 hours for one week
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr Maryam Mohamadai
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mayamohamadi63@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Maryam Mohamadai
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mayamohamadi63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Behnaz Basiri
Position
Podiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
b.basiri@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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