Comparison of the effect of breast milk smell and vanilla extract on the duration of the transition from gavage to oral feeding, weighing, and length of stay of premature infants in special care units of hospitals affiliated with Shiraz University of Medical Sciences in 2023-2024
Comparison of the effect of the smell of breast milk and vanilla extract on the duration of the transition from gavage to oral feeding, weighing, and length of stay of premature infants
Design
Clinical trial with control group, with parallel groups, randomized, 61 infants
Settings and conduct
At the beginning of the study, completing the checklist of demographic characteristics, measuring the baby's weight using a scale. In the first intervention group, olfactory stimulation with a pad soaked in 1 cc of a concentration of 6 mg in 100 cc of vanilla extract. In the second intervention group, olfactory stimulation with a pad soaked in 1 cc of breast milk. In the control group, olfactory stimulation with a pad soaked in 1 cc of sweet almond oil. After completing the interventions, re-measure the baby's weight using a scale. The place of interventions is the neonatal intensive care unit of hospitals affiliated to Shiraz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion: breastfeeding. Exclusion: Previous patient participation in studies similar to the current study.
Intervention groups
The Intervention group with mother's milk scent during gavage
The intervention group with the scent of vanilla extract during gavage
Control group, without any intervention of gavage feeding.
Main outcome variables
The duration of the transition from gavage to oral feeding, weighing, and length of stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160228026817N4
Registration date:2023-05-10, 1402/02/20
Registration timing:registered_while_recruiting
Last update:2023-05-10, 1402/02/20
Update count:0
Registration date
2023-05-10, 1402/02/20
Registrant information
Name
Neda Jamalimoghadam
Name of organization / entity
Shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 3621 5273
Email address
jamalin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-04, 1402/02/14
Expected recruitment end date
2023-08-05, 1402/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of breast milk smell and vanilla extract on the duration of the transition from gavage to oral feeding, weighing, and length of stay of premature infants in special care units of hospitals affiliated with Shiraz University of Medical Sciences in 2023-2024
Public title
Comparison of the effect of the smell of breast milk and vanilla extract on the duration of the transition from gavage to oral feeding, weighing, and length of stay of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 27-33 weeks (who have weakness and inability to suck)
Birth weight of at least 1 Kg
Apgar score greater than 6 in the first and fifth minutes
Not having any health-threatening congenital abnormalities
No underlying or acquired diseases except prematurity
Breast feeding
Exclusion criteria:
Previous patient participation in studies similar to the current study
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block method will be used and people in three groups will be assigned to 10 blocks of 6. Allocation will be done by
Random allocation software. In order to assign people to three groups, the intervention group with the scent of vanilla with the English letter A, the intervention group with the scent of mother's milk with the English letters B, and the control group with the English letters C are considered, and the different permutations of the ABC chain are written and given a code. The codes are CBA, CAB, BAC, ACB, ABC, and each time the groups are assigned, a number between 1 and 6 is randomly selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Street, in front of Palestine Street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1401.112
Health conditions studied
1
Description of health condition studied
The duration of transition from gavage to oral feeding, weighing and length of stay of premature babies
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The duration of the transition from gavage to oral feeding
Timepoint
The distance from the start of gavage feeding to oral feeding
Method of measurement
According to the patient's file
2
Description
Weighing
Timepoint
Birth weight, weight at entry into the study, and weight at the time of feeding transfer
Method of measurement
Scale
3
Description
Duration of Stay of premature babies
Timepoint
According to the patient's file
Method of measurement
Registration in the patient file
Secondary outcomes
1
Description
Improving the quality of life
Timepoint
From admission to discharge
Method of measurement
The number of hospitalization days of infants in the intervention group is compared with the control group and recorded in the designed table.
2
Description
Decreasing parental anxiety
Timepoint
Birth weight, weight at the time of intervention, and weight at the time of discharge is measured
Method of measurement
Standard digital scale available in the department
Intervention groups
1
Description
First intervention group: Vanilla. In the present study, simultaneously with the start of gavage, olfactory stimulation was performed in the intervention group with a pad soaked in 1 cc of a concentration of 6 mg in 100 ccs of vanilla extract at 9 am, 12 noon, 3 pm, and 6 pm. Gavage is completed and olfactory stimulation is removed, which continues until the mother's breastfeeding begins.
Category
Other
2
Description
The second intervention group: is breast milk. In the present study, at the same time as the gavage begins, at 9:00 AM, 12:00 PM, 3:00 PM, and 6:00 PM, olfactory stimulation is performed and in the intervention group with a pad soaked in 1 cc of breast milk, and after the end of the gavage And the olfactory stimulus is removed, which continues until the start of feeding from the mother's breast
Category
Other
3
Description
Control group: In the present study, at the same time as the gavage begins, olfactory stimulation is performed in the intervention group with a pad soaked in 1 cc of sweet almond oil at 9 am, 12 noon, 3 pm, and 6 pm, and after the end of the gavage and The olfactory stimulation is removed, which continues until the mother's breastfeeding begins.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated with Shiraz University of Medical Sciences
Full name of responsible person
Neda Jamalimoghadam
Street address
Namazee square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4257
Email
nedajamali21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
Deputy of research and technology, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand St., Shiraz, Fars, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Neda Jamalimoghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4257
Email
nedajamali21@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Jamalimoghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4257
Email
nedajamali21@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Jamalimoghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4257
Email
nedajamali21@yahoo.com
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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available