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IRCT20210905052381N1 IRCT 2021-09-20 Iran University of Medical Sciences Nutritive Sucking in Premature Infants The Effect of the combination of Kinesio-taping and Oral Motor Intervention on feeding functions of Premature Infants with Feeding Difficulties Hospitalized in the NICU 2021-09-23 anticipated 45 Complete https://irct.ir/trial/58564 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, random allocation will be done by a person who is not present in the the investigation process and does not know the groups. it will be done using the Random allocation rule. In this method, after determining the total sample size, a set of them is randomly assigned to each group and for the number of samples in each group, in the sheets, the name of the treatment group will be written briefly. The sheets will be placed in opaque envelopes and all will be placed in the container. The person who is not involved in any of the research steps will then be asked to randomly choice the envelopes and the sequence created will be recorded. Then, according to the sequence created for infants with inclusion criteria, treatment will be used, Blinding description: The staff of the department will not be aware of the treatment used. Also, the assessor (speech and language pathologist), who is someone other than the therapist, will not know about the treatment groups because the assessments will be done after the separation of the type. N/A Oral feeding disorders in premature infants. Intervention 1: Intervention group: Present PIOMI intervention before feeding and for 5 minutes a day for seven consecutive days and then use the kinesiotape of orbicularis oris muscle, mylohyoid-sternohyoid and masseter muscle for 7 consecutive days and daily change of them. Intervention 2: Intervention group: Present PIOMI intervention before feeding and for 5 minutes a day for seven consecutive days. Intervention 3: Control group: use the kinesiotape of orbicularis oris muscle, mylohyoid-sternohyoid and masseter muscle for 7 consecutive days and daily change of them and routine nursing care. 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 Undecided - It is not yet known if there will be a plan to make this available
public Ehsan Naderifar
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2675 e.naderi.slp@gmail.com Iran University of Medical Sciences scientific Leila Ghelichi
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2675 Lghelichi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) APGAR score above 5 for 5 min Absence of congenital anomalies (such as heart, mouth, etc.) or severe medical problems Gestational age between 30-34 weeks weight at birth between 1000-1500g Tube feeding no limit no limit Both R13.19 Other dysphagia Rehabilitation Rehabilitation Rehabilitation Intervention group: Present PIOMI intervention before feeding and for 5 minutes a day for seven consecutive days and then use the kinesiotape of orbicularis oris muscle, mylohyoid-sternohyoid and masseter muscle for 7 consecutive days and daily change of them. Intervention group: Present PIOMI intervention before feeding and for 5 minutes a day for seven consecutive days Control group: use the kinesiotape of orbicularis oris muscle, mylohyoid-sternohyoid and masseter muscle for 7 consecutive days and daily change of them and routine nursing care Premature Oral Feeding Readiness Scale. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Premature Oral Feeding Readiness Scale. Mean Volume Intake. Timepoint: First, fourth and seventh days of intervention. Method of measurement: % volume intake in 5 minutes divided by the prescribed volume. Weight gain. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Put the baby on a digital balance and record the baby's weight to gram. Improvement interval of oral intake. Timepoint: First, fourth and seventh days of intervention. Method of measurement: the MV from Day 1 (the baseline) will subtracted from the MV of Days 4 or 7, then will divided by the baseline. Duration of the hospitalization. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Interval between the first day of preterm infant referral to the NICU until the last day (discharge). Iran University of Medical Sciences Approved 2021-08-29 Research Ethics Committees of Iran University of Medical Sciences Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)