1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effectiveness of oral and motor-intervention with multisensory stimulation in nutritive sucking in premature infants admitted to the neonatal intensive care unit: RCT

Protocol summary

Study aim
Comparison of the effectiveness of oral motor intervention in preterm infants and its combined methods with multisensory stimulation in nutritional sucking in preterm infants admitted to the intensive care unit
Design
Clinical trial, with control group, with parallel groups, one-way blind, randomized, on 90 patients
Settings and conduct
Neonatal Intensive Care Unit
Participants/Inclusion and exclusion criteria
Inclusion criteria for preterm infants in this study include: Fetal age between 28 to 34 weeks, birth weight between 1000 and 2000 grams Receiving tube feeding, physiological stability, absence of congenital anomalies, absence of genetic syndromes, absence of neonatal obstruction, absence of untreated blood infection, absence, presence of pink cranial malformations, absence of untreated respiratory disease Exclusion criteria of this study include: Physiological instability at the beginning and during interventions of nutritional stimuli, infant death
Intervention groups
Intervention group: Combined methods (PIOMI with multisensory stimulation) For this group, in addition to performing oral movement therapy in premature infants, multisensory stimulation will also be performed. In this way, for 5 days a week, multi-sensory stimulation, which includes auditory stimulation, tactile stimulation, visual stimulation and vestibular stimulation, will be performed for 12 minutes. Touch stimulation by massaging the baby's limbs for 3 minutes, auditory stimulation By playing a lullaby in the incubator for 3 minutes, visual stimulation by hanging black and white cards inside the incubator for 3 minutes and vestibular stimulation by vertical and horizontal shaking of the baby for 3 minutes.
Main outcome variables
Determining the effectiveness of combination therapies on oral nutrition in premature infants

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211215053422N1
Registration date: 2021-12-25, 1400/10/04
Registration timing: registered_while_recruiting

Last update: 2021-12-25, 1400/10/04
Update count: 0
Registration date
2021-12-25, 1400/10/04
Registrant information
Name
Sara Abedini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5250 3788
Email address
abedini.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of oral and motor-intervention with multisensory stimulation in nutritive sucking in premature infants admitted to the neonatal intensive care unit: RCT
Public title
Comparison of the effectiveness of oral and motor-intervention with multisensory stimulation in nutritive sucking in premature infants admitted to the neonatal intensive care unit: RCT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion of premature infants in this study includes gestational age between 28 and 34 weeks Birth weight between 1000 and 2000 grams Tube feeding Physiological stability at the onset of nutritional stimulation Absence of congenital anomalies Absence of genetic syndromes Absence of oppression in infancy Absence of untreated blood infection Absence of craniofacial deformities Absence of untreated respiratory disease
Exclusion criteria:
Exclusion criteria of this study include: Physiological instability at the beginning and during nutritional stimulation interventions Infant death
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: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Individuals are divided into two groups completely randomly based on the method of 4 random blocks. The site at sealedenvelope.com is used for randomization. If we call two groups A and B. The logic of randomization is that from 6 blocks BAAB, BBAA, ABBA, ABAB, AABB and BABA, we select enough samples by placement (ie n / 4) to get the sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding: The patient has no knowledge of how to be in groups. Only those who do the intervention know how patients are grouped. The rest of the people involved in the study have no knowledge of the assignment of individuals to groups. People who do the job of measuring response variables are different from people who do the job of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan Highway, Student Dormitory of the Sisters of the Revolution
City
Ahwaz
Province
Khouzestan
Postal code
6135815751
Approval date
2021-12-11, 1400/09/20
Ethics committee reference number
IR.AJUMS.REC.1400.563

Health conditions studied

1

Description of health condition studied
Premature Infants
ICD-10 code
R63.3
ICD-10 code description
Feeding difficulties

Primary outcomes

1

Description
Fetal age, time of transition from tube feeding to independent oral feeding, feeding progress (oral recovery interval), mean weight gain, feeding efficiency (oral volume), type of intervention, POFRAS test score, duration of neonatal hospitalization
Timepoint
The beginning of the intervention and the end of the intervention
Method of measurement
Premature Oral Feeding Readiness Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Combined methods (PIOMI with multisensory stimulation)For this group, in addition to performing Premature Infant Oral Motor Intervention(PIOMI), multisensory stimulation will also be performed. Thus, daily and for 5 days a week, multisensory stimulation, which includes auditory stimulation, tactile stimulation, visual stimulation, and vestibular stimulation, will be performed for 12 minutes. Touch stimulation by massaging the baby's limbs for 3 minutes, auditory stimulation By playing the lullaby in the incubator for 3 minutes, visual stimulation by hanging black and white cards inside the incubator for 3 minutes, and vestibular stimulation by vertical and horizontal shaking of the baby for 3 minutes. In this group, the treatments will be performed by the researcher in order, so that first the multisensory treatment is performed and then the PIOMI method. The mother or the nurse of the baby are not involved in the intervention and are unaware of all the treatments received.
Category
Treatment - Other

2

Description
Control group: receiving Premature Infant Oral Motor Intervention(PIOMI) This treatment consists of 8 steps:1. C-shaped stimulation or traction of the cheek 2. Rolling the lips3. Lip curl Or Lip stretch 4. Gum massage 5. Lateral wall of tongue / cheek 6. The middle blade of the tongue / palate 7. Extract a suction 8. Support for non-nutritional sucking.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hoapital
Full name of responsible person
Dr. Majid Soltani
Street address
Imam Khomeini Medical Center of Ahvaz, Azadegan Ave, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
s.abedini.slp@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Ali Ahmadi Moghadam
Street address
Ahvaz University City,Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences and Health Services, Ground Floor
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@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
Majid Soltani
Position
Associate Professor of Speech Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd ,Ahwaz, Iran
City
Ahwaz
Province
Khouzestan
Postal code
61375-15794
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Soltani
Position
Associate Professor of Speech Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd ,Ahwaz, Iran
City
Ahwaz
Province
Khouzestan
Postal code
61375-15794
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Soltani
Position
Associate Professor of Speech Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd ,Ahwaz, Iran
City
Ahwaz
Province
Khouzestan
Postal code
61375-15794
Phone
+98 61 3311 0000
Email
info@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...