Purpose: Nasal trauma is one of the common Complications of noninvasive mechanical ventilation in newborns who are receiving noninvasive Mechanical Ventilation with nasal devices Continuous positive airway pressure (nCPAP).The aim of this study is to evaluate the efficiency of Evidence –Based caring for prevention of nasal trauma in neonates receiving nCPAP
Materials and methods: In this clinical trial, 60 newborns will be considered as two groups of usual care and cares based on Evidence -Based clinical guideline consist of before and after care. In usual care group research's data will be collected by Assessment the checklist of care and examination of the nose trauma with taking pictures from the injury and inscribes number of the file (hospital records) and date of the examination in the document.
And in the evidence-based care group, after providing evidence-based clinical guidline and teach it to the neonatal intensive care unit nurses, care should be based on clinical guidline in the field of of taking cars of non-invasive mechanical ventilation for infant will be considered. And then check the status of the care of infants with non-invasive mechanical ventilation checklist of care and after reaching optimal care conditions, sampling of evidence-based care group begins.Severity of nose trauma is divided in three groups of mild(erythema and erosion , moderate(ulceration and bleeding) and severe(necrosis). And the size of the damage will be compared based on the number of affected areas of the nose in the two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110824925N1
Registration date:2015-12-27, 1394/10/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Somayeh Pournajaf
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3221 7421
Email address
pournajafs1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Evidence -Based caring for Prevention of Nasal trauma in Neonates Receiving Noninvasive Mechanical Ventilation
Public title
Effect of Evidence -Based caring for Prevention of Nasal trauma in Neonates Receiving Noninvasive Mechanical Ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: nCPAP treatment.
Exclusion criteria : nCPAP treatment duration lower than 24 h; upper airway malformations ; patients referredfrom other centres after more than 24 h of nCPAP treatment.
Age
To 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Scince
Street address
Daneshgah st
City
Mashhad
Postal code
Approval date
2014-01-11, 1392/10/21
Ethics committee reference number
920830
Health conditions studied
1
Description of health condition studied
pressure sore
ICD-10 code
L89.9
ICD-10 code description
Decubitus ulcer and pressure area, unspecified
Primary outcomes
1
Description
prevention of nasal injury in newborn
Timepoint
daily
Method of measurement
inspection and take photos of nasal injury
2
Description
Reducing the Severity of the nose injury
Timepoint
daily
Method of measurement
inspection and take photos of nasal injury
3
Description
Reducing the size of the nose injury
Timepoint
daily
Method of measurement
inspection and take photos of nasal injury
Secondary outcomes
empty
Intervention groups
1
Description
in intervention group: use of Evidence -Based clinical guideline and then Assessment the checklist of care and examination of the nose trauma with taking pictures from the injury and inscribes number of the file (hospital records) and date of the examination in the document.
Category
Prevention
2
Description
Assessment the checklist of care and examination of the nose trauma with taking pictures from the injury and inscribes number of the file (hospital records) and date of the examination in the document.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ommul-Banin hospital
Full name of responsible person
Somayeh Pournajaf
Street address
College Of Nursing and Midwifery, Doctora Crossroads
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Somayeh Pournajaf
Street address
Daneshgah st, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh Pournajaf
Position
nurse
Other areas of specialty/work
Street address
College Of Nursing and Midwifery, Doctora Crossroads
City
Mashad
Postal code
Phone
+98 51 3221 7421
Fax
Email
pournajafs1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh Pournajaf
Position
M.A student
Other areas of specialty/work
Street address
Doctora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3221 7421
Fax
Email
pournajafs1@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
ُSomayeh Pournajaf
Position
M.A student
Other areas of specialty/work
Street address
Doctora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3221 7421
Fax
Email
pournajafs1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)