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IRCT20201221049790N1 IRCT 2021-03-03 Mashhad University of Medical Sciences 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 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 2020-12-23 anticipated 51 Complete https://irct.ir/trial/53162 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A feeding problems that occur in full-term infants.. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: Group C control group who will receive routine hospital treatment. Yes - There is a plan to make this available What will be shared: After reading and publishing the article, he will be allowed to request information. When: After printing the results To whom: Researchers in academic and scientific institutions Conditions: After reading and publishing the article, he will be allowed to request information. Where to obtain: Responsible for the project Davood Sobhani 09155041233 sobhanid@mums.ac.ir How to obtain: After reading and publishing the article, he will be allowed to request information. Comments:
public Davood Sobhani
Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University
Mashhad Iran (Islamic Republic of) 9177948959 +98 915 504 1233 Sobhanid@mums.ac.ir Mashhad University of Medical Sciences scientific Davood sobhani
Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University
Mashhad Iran (Islamic Republic of) 9177948959 +98 915 504 1233 Sobhanid@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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. 1 day 40 days Both 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 P92.8 Other feeding problems of newborn Treatment - Other Treatment - Other N/A 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. 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. Control group: Group C control group who will receive routine hospital treatment. 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. Mashhad University of Medical Sciences Approved 2020-12-23 Ethics committee of Mashhad University of Medical sciences Khorasan Razavi, Mashhad, East Door Of Ferdowsi University, Public Relations Department Of The University Mashhad Razavi Khorasan Iran (Islamic Republic of)