We conducted this randomized clinical trials for studding Early Outcome of Peripherally Inserted Central Catheter (PICC) versus peripheraly Intravenous line(PIV) in Very Low Birth Weight preterm infants.In this research 114 VLBW infants who are inborn in Alzahra teaching hospital after 3-7 days of birth; randomly will divide in two groups afte robtaining consent from the parents . For the first group peripherally Intravenous line and for second group PICC catheter will be inserted. All the infants for the first 3-7 day would have umbilical vein catheter.All tubing and conections will be change every day and dressing whenever it need too.At the time of PICC orPIV extraction a culture from the tip of the Catheres will be sent for detecting of colonization.Catheter-related bloodstream infection, hospital stay, mortality rate and local complications will be compared between two groups .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903204113N2
Registration date:2012-11-28, 1391/09/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-28, 1391/09/08
Registrant information
Name
Mohammad Bagher Hosseini
Name of organization / entity
Tabriz Universisty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
hossainm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Pediatric health research center of Tabriz university of Medical sceinces
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early Outcome of peripheraly inserted central catheter(PICC)versus peripheraly conulation(PC) in very low birth weight (VLBW)infants. infants
Public title
Benefits and complication of peripherally inserted central catheter (PICC) versus peripherally Intravenous Vein lines
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Very Low Birth Weight neonates who will be born in Al-Zahra teaching hospital of Tabriz; without lethal congenital anomaly and chromosomal disorders; Absent major congenital heart disease; Absent hemorrhagic disorders; Absent generalized skin disorders or skin infection in the site of catheter insertion; Stability of vital signs according to the opinion of Neonatologist
Exclusion criteria:
All contraindications for PICC insertion (coagulopathy; venous thrombosis; generalized skin disorders or skin infection in the site of catheter insertion; Transport the neonate to another medical centres.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tabriz university of medical sceinces
Street address
Tabriz Golgasht street. Medical University
City
Tabriz
Postal code
51666_14766
Approval date
2012-07-02, 1391/04/12
Ethics committee reference number
9184
Health conditions studied
1
Description of health condition studied
Very low Birth Weight Infants
ICD-10 code
p07.1
ICD-10 code description
Birth weitht between 1000-2499 grams
Primary outcomes
1
Description
Catheter-related bloodstream infection
Timepoint
From cathrter insertion time to discharge from hospital
Method of measurement
With clinical symptom and paraclinical evidences specially blood culture
Secondary outcomes
1
Description
Mortality rate
Timepoint
From the admition until death time
Method of measurement
according to pationt dosseir
2
Description
hospital stay duration
Timepoint
Hospitaization days from admition until discharge or death
Method of measurement
accoding to dossier data
3
Description
local complication such as skin infection
Timepoint
From insertion untill remove of catether
Method of measurement
Observation by nursing staff
Intervention groups
1
Description
After randomization in two paralel groups , UVC will remove and a PICC will place at 3-7 days after birth in one group of the study . Using sterile technique, one specially trained neonatal nurse with cooperation of Neonatology fellowship will place the PICCs.Catheters made by Vygon company with 2 French caliber with breakable introducer needles will use. Three betadine swabs, with at least 1 min drying time for each, will be use when placing the PICCs. All PICCs will place in the upper limbs; placement of these lines will confirme at T4 to T6 level by radiograph. Trained nurses are responsible for changing the PICC dressings. The PICCs will monitore daily to ensure that the PICC dressing is occlusive. when necessary, the dressing will change.
Category
Other
2
Description
In the other group after removing UVC with a clean technique, place the peripheral IV lines.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital of Tabriz
Full name of responsible person
Dr, Mohanad Bagher Hossaini
Street address
Alzahra Teaching Hospital, Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pediatric health research center of Tabriz university of medical sceinces
Full name of responsible person
Dr. Mohammad Barzegar
Street address
Pediatric Hospital , Sheshgelan Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric health research center of Tabriz university of medical sceinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medica Sceinces
Full name of responsible person
Dr. Ahmmad Safary
Position
Assistant of Neonatology
Other areas of specialty/work
Street address
Alzahra teaching hospital, Artesh street
City
Tabriz
Postal code
5165685783
Phone
+98 41 1553 9161
Fax
Email
hovalalim@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical University
Full name of responsible person
Dr. Mohammad Bagher Hosseini
Position
Associte Professor
Other areas of specialty/work
Street address
Alzahra teaching hospital, Artesh Street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
Hosseini_mb@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Dr. Ahmmad Safary
Position
Assistant of Neonatology
Other areas of specialty/work
Street address
Alzahra Teaching hospital, Artesh Street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
hovalalim@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)