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Investigating the effect of ultrasonic hemodynamic monitoring by nurses on early detection of changes in hemodynamic and physical indicators of neonates and its stabilization

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History
# Registration date Revision Id
2 2024-11-30, 1403/09/10 322988
1 2023-05-12, 1402/02/22 264471
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  • Sharing plan

    undecided
    no
    undecided
    yes
    undecided
    yes
    undecided
    no
    undecided
    yes
    undecided
    na
    undecided
    na
    There is no further information
    Due to the confidentiality of the information, there is no decision to publish the data file
    اطلاعات بیشتری وجود ندارد
    به علت محرمانه بودن اطلاعات تصمیم انتشار فایل داده ها وجود ندارد
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    The data includes premature babies who were hospitalized under the supervision of 2 doctors. Personal information cannot be published due to confidentiality and lack of parental permission. But the consequences and results are shared
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    داده ها شامل نوزادان نارسی هستند که تحت نظر 2 پزشک بستری بودند . اطلاعات شخصی به علت محرمانه بودن و عدم اجازه ی والدین قابل انتشار نیستند. اما پیامد ها و نتیجه به اشتراک گذاشته میشود
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    Beginning of the access period from 1404
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    شروع دوره دسترسی از سال 1404
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    Only researchers working in academic and scientific institutions can request access to study documents
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    فقط محققین شاغل در موسسات دانشگاهی و علمی امکان تقاضا برای دسترسی به مستندات مطالعه را دارند
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    The necessary condition for sending the request depends on sending the email at the same time as the need to use the information
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    شرلیط لازم برای ارسال درخواست منوط به ارسال ایمیل در همان زمان نیاز به استفاده از اطلاعات میباشد
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    To get the data, call 09001166090 or email Shahrzadyaseri@gmail.com
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    برای دریافت داده ها با شماره ی 09001166090 تماس گرفته شود یا با ایمیل Shahrzadyaseri@gmail.com در ارتباط باشید
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    First, the request is sent, then it is checked by the reviewer and the main researcher The response time is between 2 weeks and 1 month
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    ابتدا درخواست ارسال میشود سپس توسط مسئول بررسی کننده و محقق اصلی بررسی میشود طول مدت جوابدهی بین 2 هفته الی 1 ماه میباشد

  • Trial results

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    Yes
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    2024-12-06, 1403/09/16

    Obtaining the approval of the research plan by the ethics committee and obtaining permission from the joint organizational ethics committee of the Faculty of Nursing and Midwifery, Tehran University of Medical Sciences.

    Refer to the neonatal intensive care unit of Waliasr hospital and introduce yourself to the relevant authorities and families participating in the study .

    Obtaining informed consent from the parents of infants participating in the study and explaining the objectives of the study Selection of samples according to the inclusion criteria

    کسب تایید طرح پژوهش توسط کمیته اخلاق و اخذ مجوز  از کمیته اخلاق سازمانی مشترک دانشکده پرستاری و مامایی دانشگاه علوم پزشکی کرمانشاه

    مراجعه به بخش مراقبت ویژه ی نوزادان بیمارستان ولیعصر و معرفی خود به مسئولان مربوطه و خانواده های شرکت کننده در مطالعه

     کسب رضایت آگاهانه از والدین نوزادان شرکت کننده در مطالعه و تبیین اهداف مطالعه برای 

    انتخاب نمونه ها طبق معیار ورود به مطالعه

Protocol summary

Study aim
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: 2024-12-06, 1403/09/16
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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of the information, there is no decision to publish the data file
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
The data includes premature babies who were hospitalized under the supervision of 2 doctors. Personal information cannot be published due to confidentiality and lack of parental permission. But the consequences and results are shared
When the data will become available and for how long
Beginning of the access period from 1404
To whom data/document is available
Only researchers working in academic and scientific institutions can request access to study documents
Under which criteria data/document could be used
The necessary condition for sending the request depends on sending the email at the same time as the need to use the information
From where data/document is obtainable
To get the data, call 09001166090 or email Shahrzadyaseri@gmail.com
What processes are involved for a request to access data/document
First, the request is sent, then it is checked by the reviewer and the main researcher The response time is between 2 weeks and 1 month
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2024-12-06, 1403/09/16
Table of baseline comparison
Participant flow diagram

Obtaining the approval of the research plan by the ethics committee and obtaining permission from the joint organizational ethics committee of the Faculty of Nursing and Midwifery, Tehran University of Medical Sciences.

Refer to the neonatal intensive care unit of Waliasr hospital and introduce yourself to the relevant authorities and families participating in the study .

Obtaining informed consent from the parents of infants participating in the study and explaining the objectives of the study Selection of samples according to the inclusion criteria

Table of variable outcomes' results
Table of adverse events
First publication date
empty
Abstract of published paper
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