The relationship between oral motor intervention of preterm infants and neonatal outcomes in preterm infants admitted to neonatal intensive care unit
Design
The available sampling method will be randomization of permutation blocks with a volume of four units in each block. Sample size: 62 people
Settings and conduct
This study is a randomized clinical trial. The study population included all premature infants (diagnosed by a doctor) admitted to the neonatal intensive care unit who referred to Ayatollah Taleghani Hospital in Arak in 1400.
Participants/Inclusion and exclusion criteria
Premature infants Inclusion criteria: Premature infants aged 27 to 33 weeks of gestation who are admitted to the neonatal intensive care unit, consent of the infants' parents
Exclusion criteria: Infants with cleft palate, cleft lip and congenital malformation (based on the information recorded in the file), sepsis, heart disease, necrotizing enterocolitis, grade 3 and 4 intraventricular hemorrhage
Intervention groups
Oral motor intervention (PIOMI) in the intervention group is performed after the start of oral feeding. The control group receives routine care.
Main outcome variables
Neonatal Outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220124053823N1
Registration date:2022-02-16, 1400/11/27
Registration timing:prospective
Last update:2022-02-16, 1400/11/27
Update count:0
Registration date
2022-02-16, 1400/11/27
Registrant information
Name
Fatemeh Shahjuee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
shahjueefatemeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect between Premature Infant Oral Motor Intervention (PIOMI) and Maternal stress with neonatal outcomes in preterm neonates
Public title
"Effect of Premature Infant Oral Motor Intervention in neonatal outcomes"; "Effect of Maternal stress in outcomes in neonatal outcomes"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All premature infants aged 27 to 33 weeks of gestation
Hospitalized in the neonatal intensive care unit
Satisfaction of parents of infants
Exclusion criteria:
Infants with cleft palate, cleft lip and congenital malformation (based on information recorded in the file)
Septicemia
heart disease
Necrotizing enterocolitis
Grade 3 and 4 intraventricular hemorrhage
Age
From 189 days old to 231 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
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 arak University of Medical Sciences
Street address
Third Floor., Imam Musa Kazem Building., University Complex of the Great Prophet (PBUH)., Basij Square., Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.ARAKMU.REC.1400.130
Health conditions studied
1
Description of health condition studied
Premature Infant
ICD-10 code
P07.31
ICD-10 code description
Preterm newborn, gestational age 28 completed weeks
Primary outcomes
1
Description
Maternal stress score in the standard perceived stress questionnaire of Cohen et al
Timepoint
Before the intervention and three days after the intervention and the day of discharge
Method of measurement
Perceived stress standard questionnaire
2
Description
Nutritional tolerance score in the daily chart
Timepoint
قبل از آغاز مداخله و سه روز بعد از مداخله و روز ترخیص
Method of measurement
View
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:When oral feeding is started in premature infants, the study begins. The volume of milk tolerated will be charted each day and the amount reached to the full volume of milk, ie equivalent to 3 cc per weight, will be calculated as a full fed full cut off. After starting oral feeding, the intervention method was stimulation in the cheeks for 30 seconds and in each species twice, stimulation in the lips for 30 seconds once, budding of the lips for 30 seconds once, gingival stimulation for 30 seconds twice, stimulation of the lateral sides of the tongue and cheeks for 15 seconds once, stimulation of the middle septum of the tongue and palate for 30 seconds twice and finally non-nutritional sucking with a pacifier for two minutes and the rate of respiration and Maternal stress will also be assessed as a questionnaire. Then, the duration of full feeding and the volume of nutritional tolerance and the score of the standard perceived stress questionnaire all before the intervention and three days after the intervention and the day of discharge (to check the reduction of maternal stress) in the checklist for each patient and finally The length of hospital stay is recorded.
Category
Rehabilitation
2
Description
Control group: Parents and children receive only routine hospital care. Then, the duration of full feeding and the volume of nutritional tolerance and the score of the standard perceived stress questionnaire all before the intervention and three days after the intervention and the day of discharge (to check the reduction of maternal stress) in the checklist for each patient and finally The length of hospital stay is recorded.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Educational and Medical Center
Full name of responsible person
Fatemeh Shahjouee
Street address
west side of Imam Khomeini Street., next to Gas Companyt., Taleghani Educational Medical Center., Arak
City
arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6063
Email
It-taleghani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
DR Alireza kamali
Street address
Third Floor., Imam Musa Kazem Building., University Complex of the Great Prophet (PBUH)., Basij Square., Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Shahjouee
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran
City
tehran
Province
Tehran
Postal code
3351856639
Phone
+98 21 6522 8400
Email
shahjueefatemeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Akhundzadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
نوزادان
Street address
Third floor., School of medicin Arak University of Medical Sciences., Sardasht,. Arak
City
arak
Province
Markazi
Postal code
3319693345
Phone
+98 86 3313 6055
Email
Aziz_eghbali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Shahjouee
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran
City
tehran
Province
Tehran
Postal code
3351856639
Phone
+98 21 6522 8400
Email
shahjueefatemeh@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions will be available
Under which criteria data/document could be used
The use of data is allowed by mentioning the source
From where data/document is obtainable
Afsaneh Akhundzadeh - Sardasht - Arak University of Medical Sciences 3319693345 Aziz_eghbali@yahoo.com Fatemeh Shahjouee No. 23, Kowsar One St., 12 meters from Motahhari., Kohanz., Shahriar., Tehran 3351856639 shahjueefatemeh@gmail.com
What processes are involved for a request to access data/document
The applicant must first register his / her request through the mentioned communication channels, and after reviewing the request for information, the information will be provided on condition of confidentiality and without identity information. This process will take a minimum of one month and a maximum of 2 months.