The effect of skin care program on maintenance of nasal skin integrity in preterm infant that ventilated with nasal continuous positive airway pressure.
The aim of study is the effect of skin care program on maintenance of nasal skin integrity in preterm infant treated with nasal continuous positive airway pressure. Design of this study is a semi-experimental and study population includes 110 preterm neonates with gestational age 28-36 weeks that admitted in neonatal intensive care unit and ventilated with nasal continuous positive airway pressure. Participated neonates are will divided to 2 groups (control, intervention). Neonates in control group will receive routine care but in the intervention group neonates will cared with new nasal skin care plan since ventilated with nasal continuous positive airway pressure until separation from device. Nasal skin care include gently massage the nasal septum and bridge of the nose every 6 hours for 2 minutes, rotation between nasal prong and mask every 6 hours, rubbing the hydro-gel to nasal septum and philtrum until weaning from nasal continuous positive airway pressure and use of tetracycline 1% ointment in erythematosus tissue. Daily nasal skin integrity and nasal skin damage intensity will evaluate and compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411054617N11
Registration date:2015-02-08, 1393/11/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-08, 1393/11/19
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of skin care program on maintenance of nasal skin integrity in preterm infant that ventilated with nasal continuous positive airway pressure.
Public title
The effect of skin care program on maintenance of nasal skin integrity in preterm infant that ventilated with nasal continuous positive airway pressure.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: gestational age between 28-36 weeks; neonates with respiratory distress syndrome; receiving positive pressure oxygen through a nasal mask or prong; no congenital skin diseases; don't have congenital abnormalities in the nose; no immune system defect; parent consent for participation of infant in the study.
Exclusion criteria: intubation of newborn during the study; unwillingness of parents to continuing of study.
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Deputy of research, Tabriz University of Medical Sciences
Street address
Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz
City
Tabriz
Postal code
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
93131
Health conditions studied
1
Description of health condition studied
Relation of skin care program with maintenance of nasal skin integrity in preterm infant that ventilated with nasal continuous positive airway pressure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maitenance of Nasal skin integrity
Timepoint
Since the start of ventilation with nasal continuous positive airway pressure until occurrence skin injury, daily.
Method of measurement
By completion the Lane and Drost skin integrity scale until occurrence skin injury
Secondary outcomes
1
Description
Nasal skin injury intensity
Timepoint
Since occurrence of skin injury until weaning of device, daily.
Method of measurement
Use of nasal injury intensity scale
Intervention groups
1
Description
Infants in the control group will receive routine care which is common in that unit. Routine care includes using prong and mask with appropriate size for nares and rubbing Mupirocin ointment to nasal septum and philtrum.
Category
Prevention
2
Description
Intervention group: gently massage of the nasal septum and bridge of the nose for 2 minutes every 6 hours, rotation between nasal prong and mask every 6 hours, rubbing the hydro-gel to nasal septum and philtrum twice a day until weaning from nasal continuous positive airway pressure device and using tetracycline 1% ointment on erythematous tissue instead of hydro-gel.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational Center Affiliated Medical Sciences of Tabriz, Iran
Full name of responsible person
Sakineh Karimipoor
Street address
Bagshomal Square, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Street address
Department of Pediatric Nursing, Nursing and Midwifery Faculty, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Tabriz 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
Tabriz University of Medical Science
Full name of responsible person
Mahnaz Jabraeili
Position
MSc, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
Email
jabraeilim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Mahnaz Jabraeili
Position
MSc, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
Email
jabraeilim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Mahnaz Jabraeili
Position
MSc, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
Email
jabraeilim@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)