Apnea is one of the most common problems in premature newborns. The present study aimed to
determine the effect of olfactory stimulation by vanilla on the rate of apnea incidence in premature newborns affected by apnea of prematurity.
In this randomized controlled trial, 40 premature newborn are randomly divided into two test and control groups and are studied for 3 days. Inclusion criteria: aged less than 32 weeks; weight of less than 2000 grams; affected by apnea of prematurity without Response to Methyl Xanthine. Exclusion criteria: Distinguished apnea due to other reasons including acute infections; congenital heart illnesses; anemia (Hb<10); consumers of sedative medicines; hypoglycemia.
On first and third day, babies are monitored in terms of apnea quantity and arterial oxygen saturation changes and heartbeat. On second day, for babies in test group, 2 cc of vanilla solution is poured on a cotton piece each 12 hours and is put in incubator corner in 20-cm distance of baby head and for babies in control group, 2 cc of distilled water on a cotton and is put in 20-cm distance of baby head so that it has no contact with baby skin.The newborns of both groups will be continuously monitored for the number of apnea episodes and arterial blood oxygen saturation and heartbeat for 3 days.
General information
Acronym
AOP
IRCT registration information
IRCT registration number:IRCT2015042821982N1
Registration date:2016-07-05, 1395/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-05, 1395/04/15
Registrant information
Name
Nayer Salmani
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 6323
Email address
n.salmani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Yazd University of Medical Sciences
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of olfactory stimulation by vanillin on the range of apneal attacks in newborns affected by apnea of prematurity
Public title
Olfactory stimulation on apnea of prematurity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Babies less than 32 weeks with weight less than 32 weeks who developed immature apnea and specialists distinguish immature apnea and started Methyl Xanthine for treatment and also 4-8 hours after receiving Methyl Xanthine are started into the study.
Exclusion criteria: Distinguished apnea due to other reasons including acute infections; congenital heart illnesses; anemia (Hb<10); consumers of sedative medicines; hypoglycemia; hypocalcaemia are removed and babies with brain hemorrhage than grade 1; leukomalacia preventricular; patent dactus arterious; chromosomal disorders; brain disorders and babies with allergy to vanilla smell are not introduced into the study. During the study, babies with Hemoglobin less than 10 and babies with apnea more than 3 are connected to cpap within one hour and are out of the study.
Age
From 1 day old to 28 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization using a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Yazd University of Medical Science, Bahonar Square, Yazd
City
Yazd
Postal code
8916978477
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.SSU.REC.1395.21
Health conditions studied
1
Description of health condition studied
apnea
ICD-10 code
p28.4
ICD-10 code description
Other apnoea of newborn
Primary outcomes
1
Description
Oxygen saturation
Timepoint
First, second and third day after birth in both control and experimental groups
Method of measurement
As percentage using a pulse oximeter
2
Description
heart rate
Timepoint
First, second and third day after birth in both control and experimental groups
Method of measurement
as beat using pulse oximetry
3
Description
episods of apnea
Timepoint
First, second and third day after birth in both control and experimental groups
Method of measurement
as beat using pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Iintervention group: use 2 cc of liquid vanilla 64% within the incubator babies at a distance of 20 cm from the head and without skin contact.
Category
Prevention
2
Description
Control group: Use 2 ml of distilled water at a distance of 20 cm from the head and without skin contact
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU,Shahid Sadoughi Hospital
Full name of responsible person
Sakine Yaghoobi
Street address
Ebnesina street, Riyazi square, Shahid Ghandi Boulevard, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Yazd University of Medical Sciences
Full name of responsible person
Nayer Salmani
Street address
Yazd University of Medical Sciences,Bahonar Squre, Yazd
City
yazd
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 Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Nayer Salmani
Position
PHD of Nursing , Faculty Member
Other areas of specialty/work
Street address
Boali Alley,Timsar Falahi Street, Safaeiye, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 1751
Fax
Email
n.salmani@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing College, Yazd University of Medical Sciences