The effect of olfactory stimulation by vanillin on apnea prevention in premature infants admitted in the hospitals associated to shiraz university of medical sciences,2011
This study focuses on the effects of olfactory stimulation by vanillin on apnea in premature newborn infants. In this study, 36 premature newborn infants with 2 postnatal age, randomly select in two groups of case and control. Saturated vanillin solution is used for case group and no interventions are performed on the control group. While babies in both groups are conveniently monitored within 5 days, the occurrence of apnea, the mean of heartbeat and the mean percentage of saturated arterial blood oxygen are measured by pulsoximetry.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201078643N1
Registration date:2012-02-25, 1390/12/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-25, 1390/12/06
Registrant information
Name
Hajar Pourpulad
Name of organization / entity
Shiraz University of Medical Sciences, Fatemeh (P.B.U.H) School of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 72 1223 7301
Email address
pourpuladh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellery for Research affairs of the Shiraz University of Medical Sciences
Expected recruitment start date
2011-07-31, 1390/05/09
Expected recruitment end date
2012-01-30, 1390/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of olfactory stimulation by vanillin on apnea prevention in premature infants admitted in the hospitals associated to shiraz university of medical sciences,2011
Public title
The effect of olfactory stimulation on apnea in premature infants
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: Gestational age<36 weeks; Postnatal age: 2 day old; Birth weigth<2500gr; No need for ventilator; Absence of congenital heart disease.
The exclusion criteria: Hypocalcemia; Hypoglycemia;Hb<10; Need for ventilator; Intraventricular hemorrhage during intervention.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz
City
Shiraz
Postal code
Approval date
2011-11-03, 1390/08/12
Ethics committee reference number
CT-90-5789
Health conditions studied
1
Description of health condition studied
Apnea
ICD-10 code
J98
ICD-10 code description
Other diseases of the respiratory system
Primary outcomes
1
Description
Frequency of apnea
Timepoint
2-7 days of postnatal age
Method of measurement
Pulsoximetry
2
Description
Heart rate
Timepoint
2-7 days of postnatal age
Method of measurement
Pulsoximetry
3
Description
Oxygen saturation
Timepoint
2-7 days of postnatal age
Method of measurement
Pulsoximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On the first two days of the study a 0.04 grams of 2%-saturated vanillin solution is used every 12 hours and on the following three days, no vanillin solution is used with no intervention
Category
Prevention
2
Description
Control group: newborns are likewise under continuous monitoring but with no interventions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Pourpulad
Street address
Fatemeh (P.B.U.H) School of Nursing & Midwifery, Namazi square, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Shiraz University of Medical Sciences, Setad, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences, Fatemeh (P.B.U.H) School of Nursing & Midwifery
Full name of responsible person
Mrs Mitra Edraki
Position
Instructor, Department of Pediatric Nursing
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School of Nursing & Midwifery, Namazi square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
Mitraedraki@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences , Fatemeh (P.U.B.H) School of Nursing & Midwifery
Full name of responsible person
Mrs Mitra Edraki
Position
Instructor, Department of Pediatric Nursing
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School of Nursing & Midwifery, Namazi square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
Mitraedraki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Pourpulad
Position
Master of Science
Other areas of specialty/work
Street address
Fatemeh (P.B.U.H) School of Nursing & Midwifery, Namazi square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
Pourpuladh@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)