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Comparison effect of two methods of pacifier sucking And Mother’s finger on Oral Feeding Skills in Premature Infants

Protocol summary

Study aim
Evaluation effect of two methods of pacifier sucking And Mother’s finger on Oral Feeding Skills in Premature Infants
Design
Infants aged 31 to 33 weeks with a minimum weight of 1350 select the available samples based on the specification of the study unit. Randomized blocking face is divided into three groups: sucking pacifier, mother finger and control group receiving routine care.This study is a randomized clinical trial with control group with parallel groups with sample size of 50 people in each group.
Settings and conduct
Procedure: In the first group, the pacifier enters the baby's mouth before gavage and in the second group, the mother puts her finger in the baby's mouth. Neonates are observed 2 minutes before, during and 2 minutes after the intervention. This procedure is performed three times a day (early morning, noon and afternoon and each time for 5 minutes) for at least 10 days. And the control group receives routine care in the ward. It is a questionnaire measuring tool (PIBBS). Due to one-blind study, a nurse performs other than the primary outcome researcher (PIBBS) at the end of the study at Babol Ayatollah Rouhani Hospital with no information on how the infants are assigned to the group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age 31 to 33 weeks, minimum weight interval 1350 g, gavage feeding Exclusion criteria: any congenital malformations, especially in the jaw, mouth and palate, respiratory problems, heart
Intervention groups
Non-Nutritional Sucking Group, Immediately Before Gavage, Putting Nipple in Baby's Mouth - Non-Nutritional Sucking Mother's Group, Immediately Before Gavage, Breast Feeding for 5 Minutes in Newborn Mouth-Control Group Receives Routine Care.
Main outcome variables
Facilitation Score and Duration of Oral Nutrition, Breast Sucking Time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191116045460N1
Registration date: 2020-01-11, 1398/10/21
Registration timing: prospective

Last update: 2020-01-11, 1398/10/21
Update count: 0
Registration date
2020-01-11, 1398/10/21
Registrant information
Name
Fatemeh Shaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
f.shaki@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of two methods of pacifier sucking And Mother’s finger on Oral Feeding Skills in Premature Infants
Public title
Comparison effect of two methods of pacifier sucking And Mother’s finger on Oral Feeding Skills in Premature Infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 31 and 33 weeks Minimum weight of intervention time, 1350 g Feeding by gavage No mother's addiction to alcohol or drugs
Exclusion criteria:
Any congenital malformations, especially in the jaw, mouth and palate Including respiratory problems such as bronchopulmonary dysplasia, cardiac, convulsive, grade 4 and 3 intraventricular hemorrhage
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be randomly assigned to the permissive block method after applying entry and exit criteria. The randomization unit will be individual. By using a randomly selected block list, infants will be placed in the non-nutritious suckling group and the other group in the non-nutritious sucking group and the control group. Given that the type of intervention is such that we cannot blind the participants, we did our best to evaluate the outcome and evaluate the PIBBS by someone who did not know the sample allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Keshavarz Ave, Ayatollah Rouhani Hospital
City
babol
Province
Mazandaran
Postal code
4941779355
Approval date
2019-11-09, 1398/08/18
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.216

Health conditions studied

1

Description of health condition studied
The condition of premature infants
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Feeding behavior score
Timepoint
Measurement of feeding behavior 10 days after intervention
Method of measurement
Breastfeeding Behavior

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: non-nutritional suckling infants group in which preterm infants aged 31 to 33 weeks with a minimum body weight of 1350 g were selected and three times daily for ten days a pacifier (Pars Silicon Company product called Mina Bib Cover) Specifically) by the mother entered the baby's mouth.
Category
Behavior

2

Description
Intervention group 2: Non-nutritious suckling infants group in this group were preterm infants aged 31 to 33 weeks with a minimum weight of 1350 g and three times daily for 10 days.
Category
Behavior

3

Description
control group: In this group, preterm infants aged 31 to 33 weeks with a minimum weight of 1350 g were selected and received routine care.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol Ayatollah Rouhani Hospital
Full name of responsible person
Fatemeh shaki
Street address
Ayatollah Rouhani Hospital, Keshavarz Ave.
City
Babol
Province
Mazandaran
Postal code
4941779355
Phone
+98 11 3223 8303
Fax
Email
fatemeshaki1980@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Keshavarz Avenue
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3223 8303
Fax
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Shaki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gharbi Keshavarz Street
City
Aliabad Katul
Province
Golestan
Postal code
4941779355
Phone
+98 11 3223 8304
Email
fatemeshaki1980@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Shaki
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gharbi Keshavarz Street
City
Aliabad Katul
Province
Golestan
Postal code
4941779355
Phone
+98 11 3223 8305
Email
fatemeshaki1980@gmail.c0m

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Shaki
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gharbi Keshavarz Street
City
Aliabad Katul
Province
Golestan
Postal code
4941779355
Phone
+98 11 3223 8305
Email
fatemeshaki1980@gmail.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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