Comparison of 3 different strategies for vascular access in ELBW infants
Design
Clinical trial in three parallel groups, single blind (blinding for the data analysis team), randomized with block randomization technique, individual randomization unit and using RAS software.
Settings and conduct
Extremely low birth weight infants admitted to the neonatal intensive care unit of Mahdiyeh Hospital in Tehran will be included in the study. For the venous access of these infants, one of the three strategies mentioned above will be chosen. These babies will be followed up during hospitalization in terms of three main outcomes. Blinding will only be possible for the data analysis team.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infants with birth weight less than 1000 grams who will be admitted in NICU;
Exclusion criteria: congenital abnormalities, parents who are not consent to be in this research, insertion of UVC in delivery room in resuscitation process
Intervention groups
A: insertion of PICC at first day of life
B: insertion of UVC at first day of life . then removal of UVC at day 5 to 7 and insertion of PICC same day
C: insertion of PIV at first day of life then then removal of PIV at day 5 to 7 and insertion of PICC same day
Main outcome variables
Neonatal Death, Central Line Associated Blood Stream Infection, Intra ventricular Hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220704055362N1
Registration date:2022-12-25, 1401/10/04
Registration timing:prospective
Last update:2022-12-25, 1401/10/04
Update count:0
Registration date
2022-12-25, 1401/10/04
Registrant information
Name
Elahe Rastkar Mehrabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
elaheh.rastkar86@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of different strategies for vascular access in ELBW infants in NICU
Public title
Effect of type of vascular access in neonatal outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of neonates with birth weight less than 1000 grams who will be admitted in neonatal intensive care unit of Mahdiyeh hospital
Exclusion criteria:
Congenital abnormalities
Insertion of Umbilical venous catheter in delivery room in resuscitation process
parents do not consent to be in this research
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
183
Randomization (investigator's opinion)
Randomized
Randomization description
The classification of the samples to be assigned to the treatment groups will be done in a block random manner. The randomization unit is considered individual. RAS statistical software, block randomization tool will also be used to determine the sequence of blocks. The sealed cover letter will be used for allocation concealment.
We consider the capacity of the blocks as 6 and then we write all the possible permutations for this block, which are defined as follows.
(1: ABCABC) and (2: AABBCC) and (3: BBCCAA) and (4: BACBAC) and (5: ACBBCA) and (6: BCACAB) and...
By means of statistical software, we randomly select one of the numbers of permutations and consider the block corresponding to it. For example, if the first random selection of block 5 is selected, the first person will receive treatment A, the second person will receive treatment C, the third and fourth persons will receive treatment B, the fifth person will receive treatment C, and the sixth person will receive treatment A. To reach a sample size of 61 in each stratum, we continue this process 31 times. After selecting all the blocks, we randomly assign A, B, C to one of the treatment groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study, blinding will only be possible for the data analysis group, and this group will not know what type of intervention groups A, B, and C have received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.558
Health conditions studied
1
Description of health condition studied
Neonates with birth weight less than 1000 grams
ICD-10 code
P07.0
ICD-10 code description
Extremely low birth weight newborn
Primary outcomes
1
Description
Central Line Associated Blood Stream Infection
Timepoint
Since 24 hours after insertion of central line till 48 hours after removal. In this period whenever neonate has clinical signs of infection, blood culture will be sent.
Method of measurement
Positive blood culture in an neonate with a central venous catheter with clinical symptoms, with no other known source of infection
Secondary outcomes
1
Description
Inter ventricular hemorrhage
Timepoint
Three days after birth and then weekly for a month
Method of measurement
Reviewing of brain ultrasound report
2
Description
Neonatal mortality
Timepoint
From birth to 28 days old. Whenever it happens
Method of measurement
Direct observation and record in the medical record file
Intervention groups
1
Description
Intervention group: in this group Peripherally inserted Central Catheter (PICC) line will be inserted at first day of life
Category
Treatment - Devices
2
Description
Intervention group: In this group Umbilical Venous Catheter (UVC) will be inserted at first day of life and at day 5 to 7, UVC will be removed and Peripherally Inserted Central Catheter (PICC) will be inserted
Category
Treatment - Devices
3
Description
Intervention group: In this group Peripheral Inter venous (PIV) catheter will be inserted at first day of life and 5 to 7 days later PICC will be replaced
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh Hospital
Full name of responsible person
Ali Naseh
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
+98 21 5506 2627
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
افشین زرقی
Street address
Next to Ayatollah Taleghani Hospital ,Evin , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elahe Rastkar Mehrabani
Position
NICU nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
e.rastkar@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Naseh
Position
Assistant Professor of Neonatal-Perinatal Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
A.naseh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elahe Rastkar Mehrabani
Position
NICU nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
e.rastkar@sbmu.ac.ir
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