Influence of lateral and supine position on bacterial colonization of endotracheal tube in neonates were admitted in neonatal intensive care unit of 17 shahrivar hospital of Rasht: A comparison
The aim of this study is to investigate the effect of supine and lateral position on bacterial colonization of endotracheal tube in neonates. Thirty four neonates with gestational age ≥ 28 weeks from the last menstrual period, who do not have congenital malformations such as tracheoesophageal fistulae, chest deformities or diaphragmatic hernia that need to intubation within 48 hours of birth will be enrolled and randomly divided into two groups: group A(neonates in supine position) and B( neonates in lateral position). Demographic data and the results of routine laboratory tests will be recorded. Neonates with congenital sepsis or pneumonia and who cannot be maintained on mechanical ventilation for 5 full days will be excluded. Group A will be maintained on their backs and endotracheal tube held upright in a vertical position (routine care in our NICU) and group B subjects will be positioned on their sides (left or right) with the back supported by a rolled soft towel and endotracheal tube held in horizontal position. Researcher will culture tracheal secretions in the second and fifth days of mechanical ventilation for both groups. A single microbiologist blind to the grouping will analyze the dishes and will do the antibiogram study. Then we will compare the results of laboratory tests and bacterial colonization between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202199075N1
Registration date:2012-03-30, 1391/01/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-30, 1391/01/11
Registrant information
Name
Seyyedeh Zohreh Jalali
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1324 5126
Email address
z_jalali@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2010-03-02, 1388/12/11
Expected recruitment end date
2011-03-31, 1390/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of lateral and supine position on bacterial colonization of endotracheal tube in neonates were admitted in neonatal intensive care unit of 17 shahrivar hospital of Rasht: A comparison
Public title
Influence of position on bacterial colonization of endotracheal tube in neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age ≥ 28 weeks from the last menstrual period; tracheal intubation at postnatal age of<48 hours; absence of congenital malformations such as tracheoesophageal fistulae, chest deformities or diaphragmatic hernia. Exclusion criteria: congenital sepsis or pneumonia and mechanical ventilation less than full 5 days.
Age
To 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Vice chancellor for research, Guilan University of Medical Sciences
Street address
5 Km of Tehran road, Rasht
City
Rasht
Postal code
Approval date
2009-12-21, 1388/09/30
Ethics committee reference number
1880508504
Health conditions studied
1
Description of health condition studied
Bacterial colonization due to intubation
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure, not elsewhere classified
2
Description of health condition studied
Bacterial colonization due to intubation
ICD-10 code
T81.9
ICD-10 code description
Unspecified complication of procedure
Primary outcomes
1
Description
Bacterial colonization of endotracheal tube
Timepoint
Second and fifth days of intubation
Method of measurement
Culture of endotracheal secretions
Secondary outcomes
empty
Intervention groups
1
Description
Interventional group (group B or lateral group): In this group, neonates will be positioned on their sides with the back supported by a rolled soft towel and endotracheal tube held in horizontal position. They alternatively will be rotated to left or right lateral position by trained nurses every two hours.
Category
Prevention
2
Description
The control group (group A or supine group) will be maintained on their backs and their endotracheal tubes held upright in a vertical position (routine care in our NICU).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar hospital
Full name of responsible person
Seyyedeh Zohreh Jalali
Street address
In front of the Azodi stadium, Namju avenue, Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Tchnology, Guilan University of Medical Sciences
Full name of responsible person
Abdolrasul Sobhani
Street address
First floor, In front of Alzahra hspital, Mellat street, Namju avenue,Rasht
City
Rasht
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 and Tchnology, Guilan University of Medical Sciences
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
Guilan University of Medical Science
Full name of responsible person
Seyyedeh Zohreh Jalali
Position
Neonatologist/Assistant Professor
Other areas of specialty/work
Street address
17 Shahrivar hospital, In front of Azodi stadium, Namju avenue, Rasht
City
Rasht
Postal code
Phone
+98 13 1322 9524
Fax
Email
zj5722003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Seyyedeh Zohreh Jalali
Position
Neonatologist/Assistant Professor
Other areas of specialty/work
Street address
17 Shahrivar hospital, In front of Azodi stadium, Namju avenue, Rasht
City
Rasht
Postal code
Phone
+98 13 1322 9524
Fax
Email
zj5722003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Fatemeh Aghamahdi
Position
MD
Other areas of specialty/work
Street address
17 Shahrivar hospital, In front of Azodi stadium, Namju avenue, Rasht
City
Rasht
Postal code
Phone
+98 13 1322 9524
Fax
Email
aghamahdi79@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)