The purpose of this study is to investigate the effect of olive oil rubbing on weight gain in very low birth weight neonates. forty-six neonates will be selected with convenience sampling and they will be assigned based on time of birth alternatively in two groups of intervention (n=23) and control (n=23). the first neonate only will be assigned in control or intervention group randomly. Inclusion criteria such as birth weight between 1000 and 1500 g, physiological stability, age at least 10 days, breast milk 120 cc/kg, parent consent. Exclusion criteria include: need for respiratory support, photo therapy, congenital anomalies, sepsis and skin disease. Intervention group will be lubricated with 3 cc olive oil at 3 times daily by nurses. Neonates of each group will be weighted by digital balance at a specified hour every day until 10 days. The difference of daily weight from first day of study until 10 days between infants in the two groups will be compared at end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121319232N2
Registration date:2015-01-22, 1393/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-22, 1393/11/02
Registrant information
Name
Fahimeh Kazemian Baboli
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3538 2160
Email address
f.kazemian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Babol University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emollient therapy with olive oil on weight gain in very low birth weight neonates
Public title
The effect of emollient therapy with olive oil on weight gain in very low birth weight neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: birth weight between 1000 and 1500 g; physiological stability; age at least 10 days; breast milk 120 cc/kg; parent consent.
Exclusion criteria: need for respiratory support; photo therapy; congenital anomalies; sepsis and skin disease.
Age
From 10 days old to 20 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Keshavarz Street, Babol
City
Babol
Postal code
47976-47745
Approval date
2014-10-14, 1393/07/22
Ethics committee reference number
933868
Health conditions studied
1
Description of health condition studied
low birth weight
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight
Primary outcomes
1
Description
weight
Timepoint
At baseline until 10th day
Method of measurement
balance
Secondary outcomes
1
Description
height
Timepoint
At baseline and end of study
Method of measurement
with meter
2
Description
head circumference
Timepoint
At baseline and end of study
Method of measurement
meter
Intervention groups
1
Description
control group receive routine care only.
Category
Other
2
Description
Intervention group will be lubricated 3 times a day with 3 cc olive oil by nurses.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani Hospital
Full name of responsible person
Fahimeh Kazemian Baboli
Street address
Ganj afrooz street, University Square
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran,Iran
City
Babol
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 of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fahimeh Kazamian Baboli
Position
Master science nursing of NICU
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8290
Fax
Email
f.kazemian@mubabol.ac.ir info@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fahimeh Kazemian Baboli
Position
Master science nursing of NICU
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganj afrooz street, Babol, Mazandaran, Iran
City
Babol
Postal code
Phone
+98 11 3223 8290
Fax
Email
f.kazemian@mubabol.ac.irinfo@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fahimeh Kazemian Baboli
Position
Master science nursing of NICU
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganj afrooz street, Babol, Mazandaran, Iran
City
Babol
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)