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The effect of continuous heparin infusion on the duration of open peripheral central venous catheter (PICC) patency in preterm neonates

Protocol summary

Study aim
The effect of continuous heparin infusion on the duration of peripheral central venous catheter (PICC) patency in preterm neonates
Design
This clinical trial has a control group, with a case group (administration of 0.5 U / ml / hr intravenous fluids), randomized, double blind. The sample size will be 100 in each group.
Settings and conduct
All preterm infants (gestational age less than 34 weeks) admitted to the NICU ward of Alzahra Hospital in Tabriz, who according to the neonatal specialist, require a PICC catheter. Then premature infants with a properly implanted catheter will be randomly divided into two groups of heparin and normal saline recipients, who will not be responsible for dividing the randomes in the follow-up study. In this study, physicians, nurses, and researchers will be blind to the study groups.
Participants/Inclusion and exclusion criteria
All preterm infants (gestational age less than 34 weeks) admitted to the NICU ward of Alzahra Hospital in Tabriz, who according to the neonatal specialist, require a PICC catheter. All preterm infants (less than 34 weeks gestational age) admitted to the NICU ward of Alzahra Hospital in Tabriz will be included in the study, according to the neonatal specialist, who require a PICC catheter. Neonates with bleeding potential, grade 3 and 4 intravascular hemorrhage, newly diagnosed sepsis, thrombocytopenia, DIC, arrhythmia, and congenital malformations will be excluded. Also increased PTT (more than 71 seconds) and neonates needing to receive heparin will be excluded.
Intervention groups
Two groups of heparin and normal saline
Main outcome variables
The primary outcome is the duration of catheter use, ie the time between insertion and exit of the catheter due to obstruction.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140921019250N2
Registration date: 2020-02-20, 1398/12/01
Registration timing: retrospective

Last update: 2020-02-20, 1398/12/01
Update count: 0
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Majid Mahallei
Name of organization / entity
Department of Pediatrics, Tabriz University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 1949
Email address
m.mahallei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2019-08-23, 1398/06/01
Trial completion date
2019-08-23, 1398/06/01
Scientific title
The effect of continuous heparin infusion on the duration of open peripheral central venous catheter (PICC) patency in preterm neonates
Public title
The effect of continuous heparin infusion on the duration of central venous catheter patency in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All premature infants (gestational age less than 34 weeks) admitted to NICU ward of Alzahra hospital in Tabriz who require PICC catheter insertion
Exclusion criteria:
Infants with a bleeding tendency Grade 3 and 4 intravascular hemorrhage Newly diagnosed sepsis Thrombocytopenia DIC arrhythmia Congenital malformations Increased PTT (more than 71 seconds) Babies in need of heparin Babies in need of heparin
Age
To 9 months old
Gender
Both
Phase
4
Groups that have been masked
  • Care provider
  • Investigator
Sample size
Target sample size: 126
Actual sample size reached: 126
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all patients will be given a code and all codes will be randomly divided into two groups using randomization software. Only the person responsible for collecting the patient information and results were aware of this coding.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient information will be provided by the treating physician as well as the type of treatment and the type of each patient's coding, and only one person who is responsible for collecting study results and data and has no role in the treatment will know the coding. Treatment will also be provided to each individual in similar containers by a person responsible for collecting study results and data that does not play a role in the treatment coded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences.
Street address
Daneshgah Street
City
Tabriz
Province
North Khorasan
Postal code
0
Approval date
2019-09-27, 1398/07/05
Ethics committee reference number
IR.TBZMED.REC.1398.573

Health conditions studied

1

Description of health condition studied
Premature babies
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]

Primary outcomes

1

Description
Duration of catheter use is the time between insertion and exit of the catheter due to obstruction
Timepoint
On the first and seventh day, and immediately after the catheter was removed
Method of measurement
Sonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The study group (administration of intravenous fluids containing 0.5 U / ml / hr) will receive two dextrose-based injections containing amino acid and lipid. Unbroken heparin will also be used.
Category
Treatment - Drugs

2

Description
Control group: The study group (administration of intravenous fluids containing dextrose serum at a dose of 0.5 U / ml / hr) will receive two dextrose-based injections containing amino acid and lipid.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Dr Majid Mahallei
Street address
Alzahra Hospital of Tabriz University of Medical Sciences, Artesh Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
0
Phone
+98 41 3385 1949
Email
medicalresearchtbz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
0
Phone
+98 41 3385 1949
Email
medicalresearchtbz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Majid Mahallei
Position
Subspecialty of Neonates.
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
0
Phone
+98 41 3385 1949
Fax
Email
medicalresearchtbz@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Mahallei
Position
Subspecialty of Neonates
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children Hospital of Tabriz University of Medical Science, Sheshgelan Street, Tabriz, Eastern Azerba
City
Tabriz
Province
East Azarbaijan
Postal code
0
Phone
+98 41 3385 1949
Fax
+98 41 3556 6449
Email
mahalleim@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arezu Pourmohamad
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children Hospital of Tabriz University of Medical Science, Sheshgelan Street, Tabriz, Eastern Azerba
City
Tabriz
Province
East Azarbaijan
Postal code
0
Phone
+98 41 3385 1949
Fax
+98 41 3556 6449
Email
Arezupmd@tbzmed.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
Not applicable
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
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