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IRCT20171023036956N2 IRCT 2018-04-23 Iran University of Medical Sciences The effect of combination therapy on feeding performance in premature infants Comparison of the efficacy of combination ( oral sensory-motor stimulation, nonnutritive sucking and oral support ) versus nonnutritive sucking on feeding performance in premature infants 2018-04-25 anticipated 44 Complete https://irct.ir/trial/27471 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each premature infant with inclusion criteria will be introduced into the study group by simple random sampling. In the second step, allocation of samples will be done by random numbers, Blinding description: In the present study, both therapy methods are performed by the researcher and all stages of the assessment by an individual other than the researcher, who is blind to the intervention process. 3 difficulties in oral feeding of premature infants. Intervention 1: Intervention Group (Combinational therapy) : Infants in the combined treatment group are stimulated oral sensory stimuli for 12 minutes and 3 minutes with a pacifier, and are stimulated twice a day with an oral support technique . Intervention 2: Control Group (Non-nutritive sucking) : Infants in the non-nutritive sucking group are stimulated with a pacifier 7-8 times a day for 5 minutes. 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 The publication details of the research group have not been discussed.
public Mr Alireza Alidad
School of Rehabilitation Sciences Speech & Language Pathology department, Shahnazari St, Mirdamad Blv.
Tehran Iran (Islamic Republic of) 1545913487 +98 982122227124 alireza.alidad@gmail.com Iran University of Medical Sciences scientific Dr Leila Ghelichi
School of Rehabilitation Sciences Speech & Language Pathology department, Shahnazari St, Mirdamad Blv.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 ghelichi.i@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) An infant with a corrected gestational age of less than 36 weeks The infant's weight is proportionate to the gestational age Apgar score equal to or greater than 3 in 1 minute and equal to or greater than 5 in 5 minutes The infant does not have the ability for oral feeding no limit 6 months Both Family unwillingness to continue treatment The infant has facial abnormalities The infant has respiratory, cardiovascular, digestive and neurological problems or congenital syndromes Infants with chronic medical conditions during NICU hospitalization, such as intraventricular hemorrhage and pulmonary dysplasia R63.3 Feeding difficulties Rehabilitation Rehabilitation Intervention Group (Combinational therapy) : Infants in the combined treatment group are stimulated oral sensory stimuli for 12 minutes and 3 minutes with a pacifier, and are stimulated twice a day with an oral support technique . Control Group (Non-nutritive sucking) : Infants in the non-nutritive sucking group are stimulated with a pacifier 7-8 times a day for 5 minutes. Score of Preterm Infant Oral Feeding Readiness Assessment Scale. Timepoint: The first stage: Before the treatment, the second stage: the seventh day, the third stage: the day of the fourteenth, the fourth stage: the seventeenth day, the fifth stage: the twentieth day, the sixth stage: the twenty-third day, the final assessment stage: the day the infant is given an independent oral feeding. Method of measurement: Preterm Infant Oral Feeding Readiness Assessment Scale(Score between 0 and 36). Infant weight. Timepoint: The first stage: Before the treatment, the second stage: the seventh day, the third stage: the day of the fourteenth, the fourth stage: the seventeenth day, the fifth stage: the twentieth day, the sixth stage: the twenty-third day, the final assessment stage: the day the infant is given an independent oral feeding. Method of measurement: Scales (gr). The amount of milk received. Timepoint: Daily. Method of measurement: Syringe (ml). Duration of full oral feeding. Timepoint: The first stage: Before the treatment, the second stage: the seventh day, the third stage: the day of the fourteenth, the fourth stage: the seventeenth day, the fifth stage: the twentieth day, the sixth stage: the twenty-third day, the final assessment stage: the day the infant is given an independent oral feeding. Method of measurement: Number of days. Duration of hospitalization. Timepoint: Daily. Method of measurement: Number of days. Iran University of Medical Sciences Approved 2017-09-23 Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat highway Tehran Tehran Iran (Islamic Republic of)