Evaluation of the effect of the Propranolol administration on children with TBI admitted to Namazee Hospital
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 36 patients. Randomized blocks were used for randomization.
Settings and conduct
Study Location: PICU at Namazi Hospital in the city of Shiraz;
Study Population: Children aged 15 years or younger with moderate to severe traumatic brain injuries (GCS <13);
Type of Blinding: Double-blind;
Method of Blinding: Medications and placebos were produced with identical size, shape, and color, and specific coding on the containers allowed only the main researchers to be aware of the treatment assignments, ensuring that patients and their guardians remained unaware of the treatment type.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All patients under 15 years of age; Having moderate to severe TBI (GCS less than 13); Admitted to the PICU at Namazi Hospital, Shiraz, Southern Iran. Exclusion Criteria: Patients older than 15 years; Having mild TBI (GCS higher than 13); Not admitted to the PICU; Admitted to other hospitals or areas outside the PICU at Namazi Hospital, Shiraz.
Intervention groups
Intervention Group: Beta Blocker Group; Patients in this group received 0.5 mg/kg of propranolol orally. Control Group: Placebo Group; Patients in this group received a placebo.
Main outcome variables
Mortality rate, PICU length of stay (LOS), hospital LOS, Glasgow Coma Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161103030683N2
Registration date:2024-05-29, 1403/03/09
Registration timing:retrospective
Last update:2024-05-29, 1403/03/09
Update count:0
Registration date
2024-05-29, 1403/03/09
Registrant information
Name
mohammad sadegh masoudi
Name of organization / entity
shiraz universit of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5259
Email address
masoudims@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2024-04-07, 1403/01/19
Actual recruitment start date
2023-10-09, 1402/07/17
Actual recruitment end date
2024-03-23, 1403/01/04
Trial completion date
2024-03-23, 1403/01/04
Scientific title
Comparing the Effect of Propranolol with Placebo on the Prognosis Improvement in Children with Traumatic Brain Injuries
Public title
Effect of beta blockers on children's brain injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with Traumatic Brain Injuries
Parental consent to participate in the study
Injury Severity Scale less than 3 in chest and abdomen
Exclusion criteria:
Age over 15 years
Injury Severity Scale greater than 3 in chest and abdomen
Parental non-consent to participate in the study
Age
To 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
88
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
We use a randomized block method with a block size of four. To ensure equal representation and random distribution of participants into the experimental (group B) and placebo (group A) arms, each block will have six possible sequences—AABB, ABAB, BAAB, BABA, BBAA, and ABBA. A research assistant trained in this procedure randomly selects one sequence to determine the next four eligible patients and repeats this process to accommodate all participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
Use of pills with identical color, shape, size, and taste.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2022-09-06, 1401/06/15
Ethics committee reference number
IR.SUMS.MED.REC.1401.306
Health conditions studied
1
Description of health condition studied
Traumatic brain lesions
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Mortality rate
Timepoint
From the beginning to the end of the study
Method of measurement
The number of dead people divided by the total number of patients in each group
2
Description
GOSE is a measure for assessing patients' functional outcomes and their level of dependency following an injury.
Timepoint
At the time of discharge, 3 and 6 months after discharge
Method of measurement
It was measured using the Glasgow Coma Scale and scoring it. Scoring: from 1 (death) to 5 (significant improvement), where higher scores indicate better outcomes and greater independence.
3
Description
Length of stay in PICU
Timepoint
From the beginning to the end of the study
Method of measurement
The number of days between the admission date and the discharge date of the patient from PICU.
4
Description
Length of hospital stay
Timepoint
From the beginning to the end of the study
Method of measurement
The number of days between the admission date and the discharge date of the patient from hospital.
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the beta-blocker treatment group received 0.5 mg per kg of propranolol orally every 12 hours from the start of hospitalization until the day of discharge.
Category
Treatment - Drugs
2
Description
Control group: Control group patients used placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital, Shiraz
Full name of responsible person
Mohammad Sadegh Masoudi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
vcrdep@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
masoudims@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Masoudi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
Masoudi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Masoudi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
Masoudi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Masoudi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 5884
Email
Masoudi@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We have decided not to publish the individual participant data (IPD) in order to maintain the security and privacy of the participants. This decision particularly takes into account situations where data may contain sensitive information, and even with the removal of identifiers and personal details, there remains the possibility of indirect identification of individuals. Furthermore, in some cases, the collected data could be combined with other information sources, potentially leading to individual identification. Therefore, the decision not to publicly share the IPD stems from our respect for the rights of the participants and our commitment to upholding high ethical standards in research.