Investigating the effect of Premature infant oral motor intervention and fossil treatment approaches in term infants with inpatient swallowing disorder in neonatal intensive care unit: A clinical trial study
Evaluation of the effect of fossil and PIOMI treatment approaches in term neonates with swallowing disorder admitted to NICU: A clinical trial study
Design
The treatment sessions of each group will include 7 to 10 sessions according to the main protocol. Before and after treatment, infants' sucking skills will be assessed by their pediatrician, discharge time and fullfeeding, and the baby's swallowing status will be assessed by a speech and language specialist using the NFAS screening test.
Settings and conduct
Each method will be performed according to the main protocol table of approaches in the neonatal intensive care unit of Ghaem Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Infants longer than and equal to 37 weeks of gestation admitted to the NICU of Ghaem Hospital
2. Newborns who have difficulty swallowing and sucking for any reason related to their underlying disease (such as asphyxia, metabolic diseases, brain disorders, infections, etc.).
3. The parents of these babies want their child to participate in the study.
4. Have a swallowing disorder according to the NFAS screening test.
Exclusion criteria:
1. If parents do not want to
2. In case of progressive disease
3. In case of risk of unmanageable injury to the baby
4. Presence of congenital anomalies (cleft lip and palate)
5. Infants with chromosomal abnormalities
Intervention groups
. Samples will include full-term neonates with dysphagia randomly assigned using a random number table in three groups of 17 people.Protocol "A" will include PIOMI treatment and protocol "B" will include fossil drills. The first group will receive "A" protocol, the second group will receive "B" protocol and the control group will receive group C routine treatment.
Main outcome variables
Infant weight, hospitalization time and Fullfeeding status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201221049790N1
Registration date:2021-03-03, 1399/12/13
Registration timing:registered_while_recruiting
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Davood Sobhani-Rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3870 3136
Email address
sobhanid@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-23, 1399/10/03
Expected recruitment end date
2021-11-24, 1400/09/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Premature infant oral motor intervention and fossil treatment approaches in term infants with inpatient swallowing disorder in neonatal intensive care unit: A clinical trial study
Public title
Investigating the effect of Premature infant oral motor intervention and fossil treatment approaches in term infants with inpatient swallowing disorder in neonatal intensive care unit: A clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newborns more than and equal to 37 weeks of gestation admitted to the NICU ward of Ghaem Hospital
Term infants who have difficulty swallowing and sucking for any reason related to their underlying disease (such as: asphyxia, metabolic diseases, brain disorders, infections, etc.).
The parents of these babies want their child to participate in the study.
According to the NFAS screening test have swallowing disorders.
Exclusion criteria:
If parents do not want to
In case of progressive disease
In case of risk of unmanageable injury to the baby
Presence of congenital anomalies (cleft lip and palate)
Infants with chromosomal abnormalities
Age
From 1 day old to 40 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, first, three groups of blocked blocks for treatments were considered as codes A, B and C, and according to the first type of permuted block randomization method, the number of each group was equal to 17 people. Giving to the groups) was written on paper and by removing one of the papers as the first block and the next paper as the second block and finally the remaining paper as the third block.17 The first infant hospitalized in the first block and The next 17 infants in the second block and the other 17 infants in the third block were treated according to their code.
Blinding (investigator's opinion)
Single blinded
Blinding description
The interventions of each group will take place at a specific time in a separate room in the nICU and the parents of the participants will be unaware of the assignment of the other groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2020-12-23, 1399/10/03
Ethics committee reference number
IR.MUMS.REC.1399.473
Health conditions studied
1
Description of health condition studied
feeding problems that occur in full-term infants.
ICD-10 code
P92.8
ICD-10 code description
Other feeding problems of newborn
Primary outcomes
1
Description
The weight of the infants and the time of discharge from the hospital and check that the infant is fed in a normal volume and orally.
Timepoint
10 days after the intervention
Method of measurement
The weight and time of admission and the infant sucking status will be assessed by the speech therapist (researcher) using the neonatal swallowing assessment test and the infant fullfeeding status will be assessed by the neonatal specialist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In group A in the present study, according to the treatment protocol, the PIOMI approach will be standard and valid . These exercises are used to increase motor-oral skills and coordination of sucking, swallowing and breathing.Performing these exercises for about 5 minutes 3 times a day in group A will take time and these exercises will be performed in 10 consecutive and intensive days and after the exercises, they will be re-evaluated.
Category
Treatment - Other
2
Description
Intervention group: The exercises used to improve swallowing disorders in group B in the present study will be according to the treatment protocol of the fossil approach by Fucile et al., Which is standard and valid for full-term infants. Breathing is used. These exercises will take about 15 minutes in Group B and will be performed for 10 consecutive days.
Category
Treatment - Other
3
Description
Control group: Group C control group who will receive routine hospital treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Davood Sobhani
Street address
Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3232 5732
Email
Sobhanid@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3232 5732
Email
Sobhanid@mums.ac.ir
Web page address
https://www.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Davood Sobhani
Position
Faculty Member And Director Of Speech Therapy Group
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 915 504 1233
Email
Sobhanid@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Davood sobhani
Position
Faculty member and director of speech therapy group
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University
City
Mashhad
Province
Mazandaran
Postal code
9177948959
Phone
+98 915 504 1233
Email
Sobhanid@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Davood Sobhani
Position
Faculty Member And Director Of Speech Therapy Group
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 915 504 1233
Email
Sobhanid@mums.ac.ir
Web page address
https://www.mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
After reading and publishing the article, he will be allowed to request information.
When the data will become available and for how long
After printing the results
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
After reading and publishing the article, he will be allowed to request information.
From where data/document is obtainable
Responsible for the project
Davood Sobhani
09155041233
sobhanid@mums.ac.ir
What processes are involved for a request to access data/document
After reading and publishing the article, he will be allowed to request information.