This randomized clinical trial was conducted on 89 very low birth weight neonates. The infants were randomly allocated to either the low dose or high dose group by a simple randomization method using a table of random numbers. The low dose group was administered with 1.5 unit of heparin in each hour for one another of kilogram of body weight. high dose group received 0.5 unit of heparin for one another of milliliter of serum. blindness was done for information assessment committe. The external part of catheter was covered with sterile transparent cover. The primary outcome was the duration of time that catheter was open and not experienced occlusion. Catheter occlusion was defined as inability to push 1 cc of normal saline 0.9% with 5 milliliter syringe. The secondary outcomes were incidence of sepsis, catheter related sepsis, phlebitis, heparin induced thrombocytopenia, skin reaction, IVH and grade of IVH, blood pressure fluctuation, death rate and other cause of catheter removal(such as termination of therapy, leakage and rupture of catheter, sudden exit of catheter(
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060621910N3
Registration date:2017-06-16, 1396/03/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-16, 1396/03/26
Registrant information
Name
Behzad Barekatain
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6670
Email address
b_barekatain@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Optimal dose of heparin for patency of peripherally inserted central catheter
Public title
Evaluating the effect of high dose versus low dose of heparin in patency of peripherally inserted central catheter in very low birth weight infants in alzahra and shahid beheshti hospitals in Isfahan at 1395-1396
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: preterm infants with birth weight less than 1500 gram; An informed consent obtained from patients parents; infant needs total parentral nutrition; long-term IV medication administration; administration of hyperosmolar IV fluids. Exclusion criteria: Skin infection at insertion site; uncorrected bleeding diathesis; ongoing bacteremia or fungal infection; follow up impossibility during study.
Age
To 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The infants were randomly allocated to either the low dose or high dose group by a simple randomization method using a table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciense
Street address
Hezarjerib boulevard, Isfahan University of Medical Sciense
City
Isfahan
Postal code
Approval date
2015-11-02, 1394/08/11
Ethics committee reference number
IR.MUI.REC.1394.1.142
Health conditions studied
1
Description of health condition studied
Neonatal Sepsis
ICD-10 code
P36.9
ICD-10 code description
Bacterial sepsis of newborn, unspecified
2
Description of health condition studied
Intra Ventricular Hemorrhage
ICD-10 code
P52.9
ICD-10 code description
Intracranial (nontraumatic) haemorrhage of fetus and newborn, unspecified
3
Description of health condition studied
Catheter Related Sepsis
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
4
Description of health condition studied
Phlebitis
ICD-10 code
T82.8
ICD-10 code description
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts
Primary outcomes
1
Description
Duration of Catheter Patency
Timepoint
Daily
Method of measurement
With Normal Saline and 5 cc Syringe
Secondary outcomes
1
Description
Catheter Related Sepsis
Timepoint
during Study
Method of measurement
Culture of Catheter Tip
2
Description
Intra Ventricular Hemorrahge
Timepoint
3th and 14th and 21th days
Method of measurement
Brain Sonography
3
Description
Phlebitis
Timepoint
During Study
Method of measurement
Observation and Physical Examination
4
Description
Sepsis
Timepoint
During Study
Method of measurement
Clinical Sign and Blood Culture
Intervention groups
1
Description
In Intervention Group we prescribed 1/5 u/kg/h of Heparin Via PICC
Category
Prevention
2
Description
In Control Group we prescribed ./5 u Heparin/1 cc of Serum Via PICC
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Behzad Barekatain
Street address
Isfahan, Sofeh street
City
Isfahan
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Behzad Barekatain
Street address
Isfahan, Metal Bridge
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciense
Full name of responsible person
Mehdi Nematbakhsh
Street address
Hezarjerib boulevard, Isfahan University of Medical Sciense
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciense