The Effect of the combination of Kinesio-taping and Oral Motor Intervention on feeding functions of Premature Infants with Feeding Difficulties Hospitalized in the NICU
Examine the effects of oral stimulation combined with Kinsiotape on feeding efficiency for Premature Infants admitted to the NICU
Design
The clinical trial consisted of a control group with parallel groups, single blind, randomized, and a sample size of 45 preterm infants.
Settings and conduct
This study is a single-blind randomized clinical trial in which the evaluators will be unaware of the type of intervention that each infant will receive. This study will be carried out after receiving permission to conduct research from the Iran University of Medical Sciences in the neonatal intensive care unit of Akbarabadi Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Premature Infants
The inclusion criteria:
gestational age between 30-34 weeks
physiological stability during taping and oral stimulations
Apgar score equal or more than5 at 5 minutes after birth
birth weight between 1000 and 1500g
not receiving mechanical ventilation
no severe or chronic medical status or congenital anomalies.
The exclusion criteria:
premature infants who were transferred to other hospital or centers
physiological instability during oral intervention and taping
show skin allergies or other allergies using KT.
Intervention groups
Group 1: Premature Infant Oromotor Intervention Combined with Kinsiotape
Group 2: Premature Infant Oromotor Intervention
Group 3: Kinsiotape and routine nursing program
Main outcome variables
Premature Oral Feeding Readiness Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210905052381N1
Registration date:2021-09-20, 1400/06/29
Registration timing:prospective
Last update:2021-09-20, 1400/06/29
Update count:0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
Ehsan Naderifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4252 4658
Email address
e.naderi.slp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of the combination of Kinesio-taping and Oral Motor Intervention on feeding functions of Premature Infants with Feeding Difficulties Hospitalized in the NICU
Public title
Nutritive Sucking in Premature Infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
APGAR score above 5 for 5 min
Absence of congenital anomalies (such as heart, mouth, etc.) or severe medical problems
Gestational age between 30-34 weeks
weight at birth between 1000-1500g
Tube feeding
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, random allocation will be done by a person who is not present in the the investigation process and does not know the groups. it will be done using the Random allocation rule. In this method, after determining the total sample size, a set of them is randomly assigned to each group and for the number of samples in each group, in the sheets, the name of the treatment group will be written briefly. The sheets will be placed in opaque envelopes and all will be placed in the container. The person who is not involved in any of the research steps will then be asked to randomly choice the envelopes and the sequence created will be recorded. Then, according to the sequence created for infants with inclusion criteria, treatment will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The staff of the department will not be aware of the treatment used. Also, the assessor (speech and language pathologist), who is someone other than the therapist, will not know about the treatment groups because the assessments will be done after the separation of the type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-08-29, 1400/06/07
Ethics committee reference number
IR.IUMS.REC.1400.479
Health conditions studied
1
Description of health condition studied
Oral feeding disorders in premature infants
ICD-10 code
R13.19
ICD-10 code description
Other dysphagia
Primary outcomes
1
Description
Premature Oral Feeding Readiness Scale
Timepoint
First, fourth and seventh days of intervention
Method of measurement
Premature Oral Feeding Readiness Scale
Secondary outcomes
1
Description
Mean Volume Intake
Timepoint
First, fourth and seventh days of intervention
Method of measurement
% volume intake in 5 minutes divided by the prescribed volume
2
Description
Weight gain
Timepoint
First, fourth and seventh days of intervention
Method of measurement
Put the baby on a digital balance and record the baby's weight to gram
3
Description
Improvement interval of oral intake.
Timepoint
First, fourth and seventh days of intervention
Method of measurement
the MV from Day 1 (the baseline) will subtracted from the MV of Days 4 or 7, then will divided by the baseline
4
Description
Duration of the hospitalization
Timepoint
First, fourth and seventh days of intervention
Method of measurement
Interval between the first day of preterm infant referral to the NICU until the last day (discharge)
Intervention groups
1
Description
Intervention group: Present PIOMI intervention before feeding and for 5 minutes a day for seven consecutive days and then use the kinesiotape of orbicularis oris muscle, mylohyoid-sternohyoid and masseter muscle for 7 consecutive days and daily change of them.
Category
Rehabilitation
2
Description
Intervention group: Present PIOMI intervention before feeding and for 5 minutes a day for seven consecutive days
Category
Rehabilitation
3
Description
Control group: use the kinesiotape of orbicularis oris muscle, mylohyoid-sternohyoid and masseter muscle for 7 consecutive days and daily change of them and routine nursing care
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Ehsan Naderifar
Street address
Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 61 4254 5658
Email
e.naderi.slp@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2212
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ehsan Naderifar
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2675
Email
e.naderi.slp@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Ghelichi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2675
Email
Lghelichi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ehsan Naderifar
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2675
Email
e.naderi.slp@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
Not applicable
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