The effect of non-nutritive sucking by mother̕ s finger on feeding tolerance and attainment of independent oral feeding of preterm infants hospitalized to the neonatal intensive care unit: a Randomized Clinical Trial Study
Determine of the effect of non-nutritive sucking by mother̕ s finger on feeding tolerance and attainment of independent oral feeding of preterm infants hospitalized to the neonatal intensive care unit
Design
A clinical trial randomized with a control group, with parallel groups, single blind
Settings and conduct
In this clinical trial, 36 preterm infants with a fetal age of 26-34 weeks admitted to the neonatal intensive care unit of Imam Reza Hospital of Kermanshah are examined. In the intervention group, 5 minutes before the infant was fed with a feeding tube, the mother placed her little finger in the infant's mouth and stimulate the infant's sucking reflex and continues for 5 minutes after gavage. This procedure will continue twice daily for 10 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age 26 to 34 weeks, physiological stability with the opinion of neonatal physician.
Exclusion criteria: asphyxia at birth, heart problems and serious congenital anomalies, use of narcotic drugs, congenital malformation and abnormalities in the jaw and mouth
Intervention groups
Intervention group: for infants in this group, non-nutritive suking begins 5 minutes before the start of the gavage and continues for 5 minutes after it. This procedure will continue twice daily for 10 days.
Control group: The neonates of this group will routinely receive the gavage, but will not receive non-nutritive sucking on the mother's finger.
Main outcome variables
Volume of residual milk in 1 and 2 hours after feeding, the time to start independent oral nutrition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151220025619N4
Registration date:2018-04-08, 1397/01/19
Registration timing:prospective
Last update:2018-04-08, 1397/01/19
Update count:0
Registration date
2018-04-08, 1397/01/19
Registrant information
Name
Leila Mohammadi Pirkashani
Name of organization / entity
Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 7294
Email address
mohammadi.p@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of non-nutritive sucking by mother̕ s finger on feeding tolerance and attainment of independent oral feeding of preterm infants hospitalized to the neonatal intensive care unit: a Randomized Clinical Trial Study
Public title
The effect of non-nutritive sucking by mother̕ s finger on feeding tolerance and attainment of independent oral feeding of preterm infants hospitalized to the neonatal intensive care unit: a Randomized Clinical Trial Study
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age 26-34 week
Physiological stability with the opinion of neonatal physician
Exclusion criteria:
Asphyxia at birth
Heart problems and serious congenital anomalies
Use hypnotic drugs
Congenital malformation and abnormalities in the jaw and mouth
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The newborns are randomly divided into two random groups( intervention and control) using random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Information about the weight and age of the infants at the start of oral nutrition and the implications of the study include gastric residual volume at 1 and 2 hours after feeding, and the time to achieve independent oral nutrition for each infant in the checklist by the researcher's assistance daily. The sheet for feeding babies is reviewed and recorded. Since this person is not aware of the type of infant group, the study is done as a single blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Imam Reza Kermanshah Hospital., Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Approval date
2018-02-28, 1396/12/09
Ethics committee reference number
IR.KUMS.REC.1396.693
Health conditions studied
1
Description of health condition studied
preterm infant
ICD-10 code
p07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Residual milk volume
Timepoint
1 and 2 hours after feeding
Method of measurement
By use of syringe
2
Description
Attainment of independent oral feeding
Timepoint
Every day until attainment of independent oral feeding
Method of measurement
View and register
Secondary outcomes
1
Description
Length of hospitalization
Timepoint
Determine by the number of hospital days
Method of measurement
Count the number of hospital days
2
Description
Weight of discharge time
Timepoint
Weight of the infants is measured in time of discharge
Method of measurement
By digital scale
Intervention groups
1
Description
Intervention group: In the intervention group, 5 minutes before the infant was fed with a feeding tube, the mother placed her little finger in the infant's mouth and by moving a finger in the infant's mouth, it stimulated the infant's sucking reflex. Then the sucking started and the feeding continued in the first 5 minutes and at the same time, the infant was fed through a feeding tube. The intervention period was 10 consecutive days, and the intervention was performed twice a day.
Category
Other
2
Description
Control group: In the control group, infants receive routine feeding and care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Kermanshah Hospital
Full name of responsible person
Leila Mohammadi Pirkashani
Street address
Imam Reza Kermanshah Hospital., Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Imam Reza Kermanshah Hospital., Parasrar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Mohammadi Pirkashani
Position
Master of Science in Neonatal Intensive Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital Kermanshah., Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Mohammadi Pirkashani
Position
Master of Science in Neonatal Intensive Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Kermanshah Hospital., Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Mohammadi Pirkashani
Position
Master of Science in Neonatal Intensive Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Kermanshah Hospital., Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715838316
Phone
+98 83 3835 7294
Email
mohammadi1607@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD