Comparison Effects of Kinesiotape and oral stimulation program on Nutritive Sucking in Premature Infants Admitted to the NICU
Design
The controlled clinical trials, based on the individual, with parallel groups, double-blind, randomized and the sample size is 10 premature infants.
Settings and conduct
This study is a double-blind randomized clinical trial because the evaluator will be unaware of the effects of the type of intervention that each baby will receive. This study will be carried out from the Deputy Chancellery of Ahvaz Jundishpour University of Medical Sciences in the neonatal intensive care unit of Emam Khomeini Hospital in 2019-2020 after obtaining a license.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Premature infants with Gestational age between 28 and 34 weeks, Weight of birth between 1000 and 2000 grams, Receiving all feedings through a tube, Stable physiologic signs at the onset of feeding stimulation,
Exclusion criteria: present of congenital anomalies (such as cardiac, oral, etc.) or severe medical complications or severe problems such as bronchopulmonary dysplasia, grade III or IV intraventricular hemorrhage, necrotizing enterocolitis, present of neuropathy, present of genetic syndromes, present of asphyxia, present of sepsis, present of congenital craniofacial malformations, present of respiratory disease.
Intervention groups
One group receive oral stimulation program and another group receive Kinesiotape concomitant with oral stimulation program.The duration of the intervention is 10 days for both groups.
Main outcome variables
Feeding Progression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190515043599N1
Registration date:2019-07-18, 1398/04/27
Registration timing:registered_while_recruiting
Last update:2019-07-18, 1398/04/27
Update count:0
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
Azadeh Abedinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3101
Email address
abedinzadeh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-24, 1398/03/03
Expected recruitment end date
2019-09-25, 1398/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Kinesiotaping on Nutritive Sucking in Premature Infants Admitted to the NICU
Public title
Nutritive Sucking in Premature Infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 28 and 34 weeks
Weight of birth between 1000 and 2000 grams
Receiving all feedings through a tube
Stable physiologic signs at the onset of feeding stimulation
Exclusion criteria:
present of asphyxia
present of sepsis
present of respiratory disease
present of congenital anomalies (such as cardiac, oral, etc.) or severe medical complications or severe problems such as bronchopulmonary dysplasia, grade III or IV intraventricular hemorrhage, necrotizing enterocolitis
present of neuropathy
present of genetic syndromes
present of congenital gastrointestinal malformations
Age
From 1 day old to 20 days old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Given that the homogeneity of the studied groups is important in terms of gender and age, the covariate adaptive randomization method will be used. The first participant will be randomly assigned to one of the intervention or control groups and the next participant will be assigned to a group that has a lower age and gender attribute, respectively. Randomization will be done by Minim software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both parents of participants and outcome evaluator are unaware of the allocation of study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.AJUMS.REC.1398.147
Health conditions studied
1
Description of health condition studied
Dysphagia in premature infants
ICD-10 code
R13.19
ICD-10 code description
Other dysphagia
Primary outcomes
1
Description
Feeding Progression
Timepoint
during intervention
Method of measurement
Record of the number of days since the onset of oral feeding until the achievement of independent oral feeding
Secondary outcomes
1
Description
Weight gain
Timepoint
before intervention and Immediately after the end of the intervention
Method of measurement
Put the baby on a digital balance and record the baby's weight to gram
2
Description
Feeding proficiency
Timepoint
since the onset of oral feeding until the achievement of independent oral feeding
Method of measurement
% ml taken during the first 5 min/ml prescribed
3
Description
Sucking frequency
Timepoint
since the onset of oral feeding until the achievement of independent oral feeding
Method of measurement
number of sucking per minutes
4
Description
Feeding duration time
Timepoint
since the onset of oral feeding until the achievement of independent oral feeding
Method of measurement
All periods in which the infant had the nipple inside the mouth
Intervention groups
1
Description
Intervention group: Receiving Kinesiotape concomitant with oral stimulation program
Category
Rehabilitation
2
Description
Control group: Receiving oral stimulation program
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Azadeh Abedinzadeh
Street address
Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3222 2818
Email
abedinzadeh.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvī
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2818
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Moradi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3374 3101
Email
neginmoradist@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Azadeh َAbedinzadeh
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2818
Email
abedinzadeh.a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Azadeh Abedinzadeh
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
: 15794-61357
Phone
+98 61 3222 2818
Email
abedinzadeh.a@ajums.ac.ir
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