Comparison of the incidence of osteopenia of prematurity in preterm infants candidate for caffeine prophylaxis with the control group in the neonatal intensive care unit of Imam Khomeini (RA) and Dr. Shariati hospital complex in Tehran.
Design
Clinical trial with a control group, with parallel groups, double-blind, not-randomized, phase 3 on 38 patients.
Settings and conduct
The study sample included babies born in Imam Khomeini (RA) and Dr. Shariati hospital complex in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: babies with a fetal age of less than 32 weeks; babies who had spontaneous breathing.
Exclusion criteria: infants with major congenital anomalies, asphyxia (Hypoxic Ischemic Encephalopathy stage 2, according to Sarnat and Sarnat classification, intrauterine growth retardation, infants with to cholestasis; infants with neuromuscular disease
Intervention groups
In the intervention group, caffeine citrate 20 mg/kg (intravenous (IV)) from Kimidaro Company was prescribed as an initial dose on the first day of birth and then with 5 mg/kg (intravenous) daily as a maintenance dose for the following days until The time of discharge from the ward followed.
Main outcome variables
Premature osteopenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230914059430N2
Registration date:2024-07-21, 1403/04/31
Registration timing:retrospective
Last update:2024-07-21, 1403/04/31
Update count:0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
Asghar Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 321 1189
Email address
aghorbani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The rate of osteopenia of prematurity in premature infants who received caffeine prophylaxis in the neonatal intensive care unit: a clinical trial
Public title
Effect of caffeine in premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with a fetal age of less than 32 weeks
Infants who had spontaneous breathing
Exclusion criteria:
Neonates with major congenital anomalies
Asphyxiation
Hypoxic Ischemic Encephalopathy stage 2 , 3
Intrauterine growth retardation
Neonates with cholestasis
Neonates with neuromuscular disease
Age
From 1 day old to 56 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Both patients and nurses and research assistants did not know the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
1972-05-02, 1351/02/12
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.322
Health conditions studied
1
Description of health condition studied
Osteopenia of prematurity
ICD-10 code
M85. 88
ICD-10 code description
Other specified disorders of bone density and structure, other site
Primary outcomes
1
Description
Serum levels of calcium
Timepoint
Serum levels of calcium was evaluated at two weeks and also at the time of discharge.
Method of measurement
The records of patients
2
Description
Serum levels of phosphors
Timepoint
Serum levels of phosphor was evaluated at two weeks and also at the time of discharge.
Method of measurement
The records of patients
3
Description
Serum levels of alkaline phosphatase
Timepoint
Serum levels of alkaline phosphatase was evaluated at two weeks and also at the time of discharge.
Method of measurement
The records of patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be prescribed prophylactic caffeine citrate (20 mg/kg intravenously as an initial dose on the first day of birth and then 5 mg/kg daily as a maintenance dose for the following days until discharge from the ward).
Category
Treatment - Drugs
2
Description
Control group: standard care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital complex of Imam Khomeini (RA) and Dr. Shariati, Tehran
Full name of responsible person
Fatemeh sadat Nayari
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 912 321 1189
Email
ghorbaniasghar829@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh sadat Nayari
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 912 321 1189
Email
ghorbaniasghar829@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh sadat Nayari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 912 321 1189
Email
ghorbaniasghar829@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Asghar Ghorbani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+9128695493
Email
ghorbaniasghar829@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh sadat Nayari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 8163 3102
Email
aghorbani@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after de-identifying individuals after contacting the corresponding author
When the data will become available and for how long
The beginning of the access period from 2024
To whom data/document is available
Researchers, doctors and health decision makers
Under which criteria data/document could be used
If any data is not reported in the text of the final report and the addressee needs it, this information will be provided to the requester if it is not about the confidential information of the patients.
From where data/document is obtainable
The manager
Dr. Fatemeh sadat Nayari
What processes are involved for a request to access data/document