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IRCT20211215053422N1 IRCT 2021-12-25 Ahvaz University of Medical Sciences 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 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 2021-12-22 anticipated 90 Complete https://irct.ir/trial/60742 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Premature Infants. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I do not have a plane at the moment
public Majid Soltani
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd ,Ahwaz, Iran
Ahwaz Iran (Islamic Republic of) 61375-15794 +98 61 3311 0000 info@ajums.ac.ir Ahvaz University of Medical Sciences scientific Majid Soltani
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd ,Ahwaz, Iran
Ahwaz Iran (Islamic Republic of) 61375-15794 +98 61 3311 0000 info@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both Exclusion criteria of this study include: Physiological instability at the beginning and during nutritional stimulation interventions Infant death R63.3 Feeding difficulties Treatment - Other Treatment - Other 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. 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. 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. Ahvaz University of Medical Sciences Approved 2021-12-11 Ethics Committee of Ahwaz Jundishapur University of Medical Sciences Golestan Highway, Student Dormitory of the Sisters of the Revolution Ahwaz Khouzestan Iran (Islamic Republic of)