The effect of two maintenance doses of caffeine citrate 5 and 10 on premature retinopathy in very low birth weight infants
Design
A clinical trial with two parallel groups, three-blind, randomized with random number table on 100 patients.
Settings and conduct
This study is a three-blind clinical trial. In this study, 100 infants weighing less than 1500 grams in two equal groups, including 50 infants in each group, were included in the study, and caffeine citrate was prescribed for all these infants to prevent apnea caused by prematurity. Then the maintenance dose for each group including the first group receive caffeine at a dose of 5 mg / kg per day and the second group receive caffeine citrate at a dose of 10 mg / kg per day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All infants weighing less than 1500 grams
Exclusion criteria: Major anomalies, Metabolic disease
Intervention groups
The first group receives caffeine at a dose of 5 mg / kg per day and the second group receives caffeine citrate at a dose of 10 mg / kg per day.
Main outcome variables
Retinopathy of prematurity in very low birth weight infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210110049985N1
Registration date:2021-02-10, 1399/11/22
Registration timing:registered_while_recruiting
Last update:2021-02-10, 1399/11/22
Update count:0
Registration date
2021-02-10, 1399/11/22
Registrant information
Name
Shahram Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
sh.moradi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two maintenance doses of caffeine citrate 5 and 10 on premature retinopathy in very low birth weight infants
Public title
The effect of two maintenance doses of caffeine citrate 5 and 10 on premature retinopathy in very low birth weight infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infant who weigh less than 1500 grams.
Exclusion criteria:
Major anomalies
Metabolic diseases
Age
From 1 day old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the subjects after applying the entry and exit criteria will be randomly assigned in a block method. The randomization unit is individual. The size of the blocks is 4 and in each block, each intervention group will be repeated twice.
Blinding (investigator's opinion)
Double blinded
Blinding description
The ophthalmologist who will play the role of ROP assessor in the studied infants, the physician in charge of the treatment (project manager) and the patient (infant) will be unaware of the study process and the separation of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.MUBABOL.REC.1399.386
Health conditions studied
1
Description of health condition studied
Retinopathy
ICD-10 code
H35.1
ICD-10 code description
Retinopathy
Primary outcomes
1
Description
Retinopathy
Timepoint
According to gestational age between 4 to 6 weeks after birth.
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group receives caffeine citrate at a dose of 5 mg / kg per day.
Category
Treatment - Drugs
2
Description
Intervention group: The second group receives caffeine citrate at a dose of 10 mg / kg per day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Shahram Moradi
Street address
Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
hajipour1365@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Email
info@mubabol.ac.ir
Web page address
http://research.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Shahram Moradi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3235 4951
Email
hajipour1365@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shahram Moradi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Email
hajipour1365@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shahram Moradi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
009832346963
Email
hajipour1365@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document