Investigating the effect of ultrasonic hemodynamic monitoring by nurses on early detection of changes in hemodynamic and physical indicators of neonates and its stabilization
Determining the effect of ultrasonic hemodynamic monitoring by nurses on early detection of changes in hemodynamic and physical indicators of premature neonates and its stabilization
Design
The clinical trial has a group that is examined before and after the intervention. Single, unblinded, non-random and without a study phase on 50 patients.
Settings and conduct
The present study will be conducted as a semi-experimental clinical trial in VALIASR Hospital of Imam Khomeini Hospital Complex in Tehran.
The target population in this study will be 24 to 37-week-old neonates hospitalized in the neonatal intensive care unit. Sampling will be done among premature neonates treated by Dr. Dalili and according to the inclusion criteria.
The researcher will visit the neonatal intensive care unit of Imam Khomeini Hospital every day in the morning shifts. First, all the vital signs are checked and recorded, then under the supervision of Dr. Dalili, the USCOM device will be used for the samples. After registering the parameters, different therapeutic interventions will be performed in order to diagnose and treat the neonates in time
Participants/Inclusion and exclusion criteria
24 to 37 weeks premature neonates; Informed and written consent of parents for their neonate's participation in the research
Intervention groups
The intervention in this research is the use of ultrasonic cardiac output monitoring (USCOM) device on 24 to 37 weeks neonates.
According to the parameters given by the device (which are several hemodynamic parameters), appropriate treatment and intervention methods such as positioning, fluid therapy, etc. are performed on them
Main outcome variables
The main result of this study is the early detection of hemodynamic disorders in neonates, which leads to faster treatment, better weighing of the neonates, and faster discharge from the hospital.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220831055840N1
Registration date:2023-05-12, 1402/02/22
Registration timing:prospective
Last update:2023-05-12, 1402/02/22
Update count:1
Registration date
2023-05-12, 1402/02/22
Registrant information
Name
Shahrzad Yaseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8843 8521
Email address
shahrzadyaseri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2023-07-24, 1402/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of ultrasonic hemodynamic monitoring by nurses on early detection of changes in hemodynamic and physical indicators of neonates and its stabilization
Public title
Investigating the effect of ultrasonic hemodynamic monitoring on early detection of changes in hemodynamic and physical indicators of neonates and its stabilization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
24 to 37 weeks premature neonates
Informed and written consent of parents for their neonate's participation in the research
Exclusion criteria:
Parents unwillingness to continue participating in the study
Morbidity or death of neonates
Having emphysema
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran's imam khomeini Hospital
Street address
First Floor., No. 72, Soraya Alley., Adibi street., Shariati street
City
Tehran
Province
Tehran
Postal code
1613633581
Approval date
2022-12-28, 1401/10/07
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.254
Health conditions studied
1
Description of health condition studied
Hemodynamic Disorders of Neonates
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of neonates with changes in hemodynamic indicators
Timepoint
At the beginning of the study and six weeks after the start of the intervention
Method of measurement
The monitoring device of the company Poindangan Rah Saadat and the ultrasonic monitoring device of cardiac output
2
Description
Percentage of neonates with changes in physical indicators
Timepoint
At the beginning of the study and six weeks after the start of the intervention
Method of measurement
Scales of Seka
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is performed on neonates aged 24 to 37 weeks. First, their monitoring is done and recorded by the monitoring device of the company Poyandegan Rah Saadat, and then the ultrasonic cardiac output monitoring device is used to check and record the changes in the hemodynamic and physical indicators of the newborns. If needed, interventions such as drug therapy, fluid therapy, position change, and oxygen therapy will be performed by the relevant doctor, and these interventions will continue until the baby's condition stabilizes
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Shahrzad Yaseri
Street address
second floor, neonatal special care department, Valiasr complex,, Imam Khomeini Hospital Complex, Dr. Gharib Street, the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1420
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jamaluddin Bagjani
Street address
1st building, 3rd floor, Faculty of Nursing and Midwifery, Dr. Mirkhani St., (Nusrat East), Toheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 4411
Email
Higher_education@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Shahrzad Yaseri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO72, Soraya Alley, Adibi Street ,Shariati Street
City
Tehran
Province
Tehran
Postal code
1613633581
Phone
+98 21 8843 8521
Fax
Email
shahrzadyaseri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Yaseri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO72, Soraya Alley, Adibi Street ,Shariati Street
City
Tehran
Province
Tehran
Postal code
1613633581
Phone
+98 21 8843 8521
Fax
Email
shahrzadyaseri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Yaseri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO72, Soraya Alley, Adibi Street ,Shariati Street
City
Tehran
Province
Tehran
Postal code
1613633581
Phone
+98 21 8843 8521
Fax
Email
shahrzadyaseri@gmail.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