Background and Aim: Many of premature infant suffer from disabilities such as intellectual, somatic even nervous and psychic during their life. Their condition depends on their growth medium. To reduce these effects, using olfactory stimulation should be one of important nursing care in NICU. So the aim of this paper was to detect: the effect of breast milk odor and formula odor on physiologic parameter and weight changes in premature born infants. Method: This study is controlled trial. The research population are 180 premature infant with gestational age 30-34 weeks of Hazrat Zeinab hospital in Shiraz. Olfactory Interventions with breast milk, formula odor and distill water will be done for three experimental group. The control group has no olfactory stimulation. The intervention will be done in 120 second, twice a day for the first week after birth. Data analysis will be done with repeated measurement, one way ANOVA and kruskal Wallis test.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014070818397N1
Registration date:2014-09-03, 1393/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-03, 1393/06/12
Registrant information
Name
Seyedeh Narjes Dehghanian
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 72 8222 9690
Email address
dehghaniann901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhd University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-09-20, 1393/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of breast milk odor on physiologic parameter and weight in premature neonate
Public title
clinlcal trial, effect of breast milk odor and formula milk odor and distilled water on physiologic parameter and weight changes in premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 24 hours after birth; gestational age 30 until 34 at birth; caring in incubator;
Stable physiologic parameter; body temperature 36.2 until 37.2; Apgar higher than 7 at minute 5 after birth; spontaneous respiration infant does not need ventilator; the mother does not smoke cigarette or use drugs and alcohol; no sign of major congenital abnormality and infection.
Exclusion criteria: the parents don’t like to continue participation in research; secondary infection; convulsion; recurrent apnea; need to ventilator or cpap; Intraventricular hemorrhage grade 3 or 4 based on brain sonography on third day ; discharge and expire before completion of intervention.
Age
To 7 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomize was done with random number
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
2
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Avenue, Mashhad
City
Mashhad
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
920831
2
Ethics committee
Name of ethics committee
mashhad university of medical science
Street address
ebn-e - sina avenue
City
mashhad
Postal code
9137913199
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
920831
Health conditions studied
1
Description of health condition studied
PHYSIOLOGIC PARAMETER AND WEIGHT
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services
Primary outcomes
1
Description
weight
Timepoint
daily for 1 week
Method of measurement
gram
2
Description
heart rate
Timepoint
before and after stimulation, twice a day for 1 week
Method of measurement
beat/ min
Secondary outcomes
1
Description
respiratory rate
Timepoint
during stimulation, twice a day for 1 week
Method of measurement
beat/min
Intervention groups
1
Description
1-Intervention group1: breast milk odor, 1.5 cc of breast milk odor pour on a 4*4 gauze put in 3 centimeters far from infants nostril.
Category
Prevention
2
Description
2-Intervention group2: formula odor, 1.5 cc of just diluted formula milk from Bebelac company pour on a 4*4 gauze put in 3 centimeters far from infants nostril.
Category
Prevention
3
Description
3-Intervention group3: distilled water, 1.5 cc of distilled water pour on a 4*4 gauze put in 3 centimeters far from infants nostril.
Category
Placebo
4
Description
4- control group: no intervention will be done and just expose to environmental odor.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Dr. Shahnaz Pourarian
Street address
Defa moghadas square, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
College of Pharmacy, Pardis daneshgah,Vaikil abad bolvar, 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 Science
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 Sience
Full name of responsible person
Narjes Dehghanian
Position
student postgaduate
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Ebn e sina street, Daneshgah avenue
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
nms.it@mums.ac.ir; dehghaniann901@ mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Soheila Karbandi
Position
Master of Science Degree
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Ebn e sina srteet, Daneshgah avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
nms.it@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Seyedeh Narjes Dehghanian
Position
Master of science student
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Ebn e sina street, Daneshgah avenue