Investigation of the effectiveness of Premature Infant Oral Motor Intervention on feeding performance of infants admitted to the NICU
Design
Clinical trials with intervention and control group, parallel-group design, based on the individual, double-blind, randomized, and the sample size is 20 premature infants.
Settings and conduct
This study is a double-blind randomized clinical trial because Both parents of participants and the outcome evaluator are unaware of the allocation of study groups. The infants will be randomly assigned to two intervention and control groups. the intervention group will receive oral motor stimulations for 5 minutes per day for 7 consecutive days and the control group will receive routine nursing care services. This study will be performed in the NICU of Imam Khomeini Hospital in Ahvaz.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Born with a gestational age of 29-32 weeks, The birth weight is between 1000 to 2000 grams and Physiological stability at the time of receiving oral stimulations. exclusion criteria: the existence of chronic medical complications, the existence of congenital anomalies(eg, heart, oral, etc), the existence of Necrotizing enter colitis(NEC), the existence of a brain injury (including intra-ventricular hemorrhage greater than grade 1), the existence of a history of prenatal illicit drug exposure, and receiving assistive ventilation (other than high-flow nasal cannula).
Intervention groups
Infants in the intervention group will receive PIOMI for 5 minutes per day for 7 consecutive days and the infants in the control group will receive routine nursing care services.
Main outcome variables
Early Feeding Skills (EFS) Assessment score in preterm infants; Feeding Progression; Sucking frequency; Feeding proficiency; The transition time from gavage to independent oral feeding; Length of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200908048663N1
Registration date:2020-11-21, 1399/09/01
Registration timing:registered_while_recruiting
Last update:2020-11-21, 1399/09/01
Update count:0
Registration date
2020-11-21, 1399/09/01
Registrant information
Name
Rezvan Isazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4263 0635
Email address
isazadeh.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-11, 1399/08/21
Expected recruitment end date
2021-02-09, 1399/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effectiveness of Premature Infant Oral Motor Intervention on feeding performance of infants admitted to the NICU
Public title
Investigation of the effectiveness of Premature Infant Oral Motor Intervention on feeding performance of infants admitted to the NICU
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Born with a gestational age of 29-32 weeks
The birth weight is between 1000 to 2000 grams
Physiological stability at the time of receiving oral stimulations
Exclusion criteria:
Existence of chronic medical complications
Existence of congenital anomalies(eg, heart, oral, etc)
Existence of Necrotizing enter colitis(NEC),
Existence of a brain injury (including intra-ventricular hemorrhage greater than grade 1)
Existence of history of prenatal illicit drug exposure
Receiving assistive ventilation (other than high-flow nasal cannula)
Age
From 203 days old to 224 days old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple and using the https://www.randomizer.org site.
Blinding (investigator's opinion)
Double blinded
Blinding description
Infants' mothers and an individual other than the researcher. The intervention is performed by the principal researcher and the evaluations are performed by an individual other than the researcher. In this study, the outcome evaluator does not know about the grouping of infants
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
2019-07-06, 1398/04/15
Ethics committee reference number
IR.AJUMS.REC.1398.265
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
The Early feeding skills (EFS) assessment instrument score in preterm infants
Timepoint
At the time of the first oral feeding, the time of discharge and one week after discharge
Method of measurement
The Early feeding skills (EFS) assessment instrument in preterm infants (This checklist contains 26 items that each item can score 1, 2, or 3)
2
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
3
Description
The transition time from gavage to independent oral feeding
Timepoint
Daily
Method of measurement
Record the number of days since the onset of gavage feeding until the achievement of independent oral feeding
Secondary outcomes
1
Description
Maintenance
Timepoint
One week after discharge from the hospital
Method of measurement
The Early Feeding Skills (EFS) Assessment instrument in preterm infants
2
Description
Length of hospital stay
Timepoint
Daily
Method of measurement
Record the number of days from the time the infant is admitted to the NICU until discharge
3
Description
Weight gain
Timepoint
At the time of enrollment, the first oral feeding, independent oral feeding, and the time of discharge from the hospital
Method of measurement
Put the infant on a digital balance and record the infant's weight to gram
4
Description
Feeding proficiency
Timepoint
From the initiation of oral feeding to the time of hospital discharge
Method of measurement
% ml taken during the first 5 min/ml prescribed
5
Description
Sucking frequency
Timepoint
From the initiation of oral feeding to the time of hospital discharge
Method of measurement
Number of sucking per minutes
Intervention groups
1
Description
Intervention group: 5 Minute massage in and around the mouth using a PIOMI protocol, once a day for seven days
Category
Rehabilitation
2
Description
Control group: Receiving routine medical and nursing services. They do not receive any speech therapy intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Rezvan Isazadeh
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3222 2818
Email
Isazadeh.r@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badwi
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
Associate 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
Rezvan Isazadeh
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
Isazadeh.r@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Rezvan Isazadeh
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
Isazadeh.r@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
Undecided - It is not yet known if there will be 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