Determining the effect of smell of breast milk on weight and physiological criteria of premature infants
Design
A single blind randomized clinical trial with an intervention and a control group and a parallel group design.
Settings and conduct
The research is carried out in the NICU section of Imam Reza Hospital. The number of 150 newborns who have entry criteria are selected and after explaining the purpose of the research to parents and obtaining written consent from the parents are included in the study. The infants are then randomly divided into two groups of intervention and control
Participants/Inclusion and exclusion criteria
Inclusion criteria: The infant's age from the second birthday; the gestational age from 30 to 34 weeks; the fifth minute Apgar greater than 7; the baby's weight from 1000 to 1500 grams.
Non-inclusion criteria: frequent apnea in neonates and the need for mechanical ventilation; secondary infection; seizure and intraventricular hemorrhage; infant death; Baby discharge and congenital anomalies.
Intervention groups
In the intervention group, breast milk is poured by syringe 1 CC around the mouth of the infant and rubbed with a pointed finger every 3 hours.
In the control group, Sterile water is poured by syringe 1 CC around the mouth of the infant and rubbed with a pointed finger every 3 hours.
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breast milk smell on weight and physiological criteria of premature infants
Public title
The effect of breastfeeding on the weight of newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Beginning in day 3
30 to 34 weeks gestational age
5-minute apgar more than 7
birth weight between 1000 to 1500 grams
Exclusion criteria:
frequent apnea in neonates and the need for mechanical ventilation
secondary infection
seizure and intravenous bleeding
anomalies Congenital
Age
From 2 days old to 30 days old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be carried out with simple randomization. In this way, 150 newborns with entry criteria by stratified randomization are selected and after explaining the purpose of the study, they will enter the parents to obtain written consent from their parents. The infants are divided into two groups of intervention and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that the babies do not have the necessary knowledge in this regard and the mothers have not been informed about this study, the study is therefore one-way blind and only the researcher who is performing the study knows.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreyshi Building- Daneshgah St- Mashhad- Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.734
Health conditions studied
1
Description of health condition studied
preterm infants
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Weight of premature infants
Timepoint
The baby's weight is monitored and recorded daily and from the second day of birth (the first day of sampling), half an hour after breast feeding to the baby's mouth.
Method of measurement
balance
2
Description
Percentage of arterial blood saturation
Timepoint
the duration of one week is 8 hours, 8, 14 and 22 hours every 8 hours and recorded in daily information. The remaining days are also checked for 8 weeks at 8, 14 and 22 hours for 1 week.
Method of measurement
questionnaire
3
Description
Infant heart rate
Timepoint
the duration of one week is 8 hours, 8, 14 and 22 hours every 8 hours and recorded in daily information. The remaining days are also checked for 8 weeks at 8, 14 and 22 hours for 1 week.
Method of measurement
questionnaire
4
Description
Infant respiratory rate
Timepoint
the duration of one week is 8 hours, 8, 14 and 22 hours every 8 hours and recorded in daily information. The remaining days are also checked for 8 weeks at 8, 14 and 22 hours for 1 week.
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: preterm newborns with birth weight between 1000-1500 gr. In the intervention group, breast milk is poured by syringe 1 CC around the mouth of the infant and rubbed with a pointed finger every 3 hours.
Category
Treatment - Drugs
2
Description
In the control group, Sterile water is poured by syringe 1 CC around the mouth of the infant and rubbed with a pointed finger every 3 hours.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Fatemeh Parvin
Street address
Imam Reza hospital, Ibn Sina Ave
City
Mashahd
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
parvinf1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreyshi building, Daneshgah Avenue
City
Mashahd
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
parvinf1@mums.ac.ir
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 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Parvin
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Imam Reza hospital, Ibn Sina avenue
City
Mashahd
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
parvinf1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
َAshraf Mohammadzadeh
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Neonatal Intensive Care Unit, Imam Reza hospital, Ibn Sina Ave-
City
Mashahd
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 513852121
Email
mohamadzadeha@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Parvin
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Neonatal Intensive Care Unit, Imam Reza hospital, Ibn Sina avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
parvinf1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Title and more details about the data/document
Some of the patient information present in the questionnaire will be available to people via e-mail.
Corresponder email: nrc@mums.ac.ir
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
En Available to academic and academic researchers
Under which criteria data/document could be used
After publishing it as a paper for the public and researchers from academic medical institutions
From where data/document is obtainable
google- ISI
What processes are involved for a request to access data/document
In search sites, the use of the effect of breastfeeding smell,Physiological criteria, preterm newborn