1. Home
  2. Approved trials
  3. » فارسی

The effect of a new combination of total parental Nutrition on the treatment process of newborns admitted to the ICU

Protocol summary

Study aim
Given the known side effects of TPN including sepsis, electrolyte abnormalities and cost, we prepared to compare the two ways of preparing TPN (The usual method of manual preparation in the ward by a nurse in compression with a clinical pharmacologist making it in sterile conditions ). Identify the preferred method that is associated with the least side effects and is also useful in cost effectiveness theory and that we submit our review to other health centers in the country.
Design
The clinical trial study was a randomized, single-blind, control group. The study population is all neonates admitted to NICU ward of Kashan Shahid Beheshti Hospital who will undergo TPN. The sample size was 26 people in each group. All infants with TPN indication were randomly divided into 4 groups using 4 blocks. The two groups were matched for sex, gestational age, and birth weight.
Settings and conduct
First group consists of infants who, provide all the contents of the TPN as provided by the neonatal care nurse to the patient within the ward. The second group will be attached to the TPN as directed by the physician in a fully sterile package, directly to the infant without any nurse manipulation. The contents of both TPNs were similar, in the first group the TPN contents were injected separately but in the second group, the TPN contents were combined and infused into an infusion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All neonates admitted to the neonatal intensive care unit who have a scientific indication of TPN onset. Exclusion criteria: Parental dissatisfaction Sepsis Get worse Receive TPN in less than 5 days
Intervention groups
The intervention group receives a standard TPN compound prepared by the clinical pharmacologist in sterile conditions.
Main outcome variables
Mortality, Hospitalization, Neonatal weight gain, Sepsis,Thrombophlebitis, Skin necrosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181028041485N2
Registration date: 2020-02-05, 1398/11/16
Registration timing: retrospective

Last update: 2020-02-05, 1398/11/16
Update count: 0
Registration date
2020-02-05, 1398/11/16
Registrant information
Name
Morteza Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4648
Email address
yousefi.m@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2018-09-22, 1397/06/31
Actual recruitment end date
2019-04-19, 1398/01/30
Trial completion date
2019-05-04, 1398/02/14
Scientific title
The effect of a new combination of total parental Nutrition on the treatment process of newborns admitted to the ICU
Public title
The effect of new Total Parental Nutrition formula on infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All neonates admitted to the neonatal intensive care unit who have a indication of starting TPN.
Exclusion criteria:
Parental dissatisfaction Sepsis Getting worse Receive TPN in less than 5 days
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 52
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent from the parents of infants, all infants with TPN indication will be randomly divided into 4 groups using 4-sided blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, neonates who were originally participants were blinded The data analyzer also analyzes the data with groups A and B.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Hekmat Street 56, Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1397.072

Health conditions studied

1

Description of health condition studied
premature neonates nutrition
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Number of days admitted
Timepoint
The end of the study
Method of measurement
Day

2

Description
Neonate weight gain
Timepoint
Every two days
Method of measurement
Kilogram

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They are infants with TPN indication, that the TPN order is sent to the hospital's Combined Drugs Center, which has a sterile chamber and a negative pressure ventilator as directed by the treating physician, and the TPN contents center is provided by the pharmacist in fully sterile conditions. They were packaged in full packages and transported to the neonatal care unit and connected directly to the infant without any manipulation.
Category
Treatment - Drugs

2

Description
Control group: They are infants who, according to the usual procedure, have all the contents of the TPN prepared and delivered to the patient by a neonatal nurse within the ward.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
MohammadReza Sharif
Street address
Boulevard Ravandi Boulevard, Hekmat Street 56
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Email
Sharif_m@Kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr HamidReza Banafsheh
Street address
Boulevard Ravandi Boulevard, Hekmat Street 56
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr MohammadReza Sharif
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Shahid Beheshti Hospital, Hekmat Street 56, Qotb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 913 260 1259
Email
Sharif_m@Kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr MohammadReza Sharif
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Shahid Beheshti Hospital, Hekmat Street 56, Qotb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 913 260 1259
Email
Sharif_m@Kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr MohammadReza Sharif
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Shahid Beheshti Hospital, Hekmat Street 56, Qotb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 913 260 1259
Email
Sharif_m@Kaums.ac.ir

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected data is shareable and has no limitations
When the data will become available and for how long
The access period will be available after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
There is no limitation
From where data/document is obtainable
Deputy of Research of Kashan University of Medical Sciences
What processes are involved for a request to access data/document
The data are visible after request from the deputy of research and after confirmation of the request within one month
Comments
Loading...