This study aimed to study effect of sunflower oil for prevention of nosocomial infection among preterm neonates.
Design
This randomized clinical trial was performed on 60 premature infants (<34 week gestation) hospitalized in the NICU, Ghaem hospital. The patients were randomly assigned to two sunflower oil massage (n=27) and control group (n = 33) based on random numbers. The body surface of infants was massaged by sunflower oil, 3 times a day up to 2 weeks and then twice a day until 28 days.
Settings and conduct
In this questionnaire, confounding factors such as underlying illness, drug intake, etc. were considered and the neonates with these factors were excluded from the study. Initial blood cultures were done for all newborn infants and secondary blood cultures were performed for infants with suspected systemic infection. The status of the skin was assessed on days 1, 3, 7, 14, 21 and 28.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Premature infants (<34 week or<1800 gr ).
Exclusion Criteria: Neonates requiring mechanical ventilation; Major anomalia in neonates; Extensive surgery; Known immunodeficiency defects; death within 48 hours of entering research.
Intervention groups
Sunflower oil massage for intervention group and massage without oil for control group were used.
Main outcome variables
Nosocomial infections
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130120012197N3
Registration date:2017-12-03, 1396/09/12
Registration timing:retrospective
Last update:2017-12-03, 1396/09/12
Update count:0
Registration date
2017-12-03, 1396/09/12
Registrant information
Name
Maryam Zakerihamidi
Name of organization / entity
Tonekabon Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 19 1224 5014
Email address
maryamzakerihamidi@yahoo.co.nz
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to compare the effects of topical sunflower oil and massage in preventing nosocomial infections in preterm infants
Public title
Effect of topical sunflower oil in preventing nosocomial infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants (<34 week or<1800 gr )
Exclusion criteria:
Neonates requiring mechanical ventilation
Major anomalia in neonates
Extensive surgery
Known immunodeficiency defects
death within 48 hours of entering research
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is done using random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashahd University of Medical Sciences, Mashhad, Iran
Street address
Mashahd University of Medical Sciences, Daneshgah Ave., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
4661734666
Approval date
2006-08-29, 1385/06/07
Ethics committee reference number
IR.MUMS.REC.1385.152
Health conditions studied
1
Description of health condition studied
Status of cutaneus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nosocomial Infections
Timepoint
1, 3, 7, 14, 21 and 28 days after birth
Method of measurement
Blood Culture
Secondary outcomes
1
Description
Duration Hospitalization
Timepoint
1, 3, 7, 14, 21 and 28 days after birth
Method of measurement
Days of hospitalization
2
Description
Duration of hospitalization
Timepoint
Up to discharge time
Method of measurement
Number
Intervention groups
1
Description
Use of Golshad sunflower seed oil of Kashmar. in the NICU hospital Ghaem two oil massage sunflower oil (n=27) and controls (n = 33) were performed. The body surface of infants up to 2 weeks and then twice to three times daily for 28 days with sunflower oi
Category
Prevention
2
Description
Control group: Lack of massage with sunseed oil
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Ghaem Hospital
Full name of responsible person
Mostafa Dastani
Street address
Ghaem Hospital and Research Center, Ahmad Abad Ave, Dr Shariati Square (Taghi Abad), Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
4661734666
Phone
+98 51 3467 8976
Email
maryamzakerihamidi@yahoo.co.nz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi Building, Daneshgah Av., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
4661734666
Phone
+98 51 2345 6346
Email
maryamzakerihamidi@yahoo.co.nz
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Zakerihamidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Obstetrics Department, Islamic Azad University, Vali Abad Ave., Tonekabon, Mazandaran, Iran
City
No 251, Laleh Blind Alley, Golesorkhi Av., Chaloos
Province
Mazandaran
Postal code
4661734666
Phone
+98 11 5224 5014
Fax
Email
maryamzakerihamidi@yahoo.co.nz
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Boskabadi
Position
Pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
4661734666
Phone
+98 51 3841 1538
Fax
+98 51 3841 1538
Email
boskabadih@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The Islamic Azad University of Tonekabon
Full name of responsible person
Maryam Zakerihamidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University, Vali Abad Ave., Tonekabon, Mazandaran, Iran
City
Tonekabon
Province
Mazandaran
Postal code
4661734666
Phone
+98 11 5224 5014
Fax
+98 11 5224 5014
Email
maryamzakerihamidi@yahoo.co.nz
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available