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IRCT20190515043599N1 IRCT 2019-07-18 Ahvaz University of Medical Sciences Nutritive Sucking in Premature Infants Effectiveness of Kinesiotaping on Nutritive Sucking in Premature Infants Admitted to the NICU 2019-05-24 anticipated 10 Complete https://irct.ir/trial/39598 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Given that the homogeneity of the studied groups is important in terms of gender and age, the covariate adaptive randomization method will be used. The first participant will be randomly assigned to one of the intervention or control groups and the next participant will be assigned to a group that has a lower age and gender attribute, respectively. Randomization will be done by Minim software, Blinding description: Both parents of participants and outcome evaluator are unaware of the allocation of study groups. N/A Dysphagia in premature infants. Intervention 1: Intervention group: Receiving Kinesiotape concomitant with oral stimulation program. Intervention 2: Control group: Receiving oral stimulation program. 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 No more information
public Negin Moradi
Golestan St
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3374 3101 neginmoradist@gmail.com Ahvaz University of Medical Sciences scientific Azadeh ŮŽAbedinzadeh
Golestan St
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3222 2818 abedinzadeh.a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Gestational age between 28 and 34 weeks Weight of birth between 1000 and 2000 grams Receiving all feedings through a tube Stable physiologic signs at the onset of feeding stimulation 1 day 20 days Both present of asphyxia present of sepsis present of respiratory disease present of congenital anomalies (such as cardiac, oral, etc.) or severe medical complications or severe problems such as bronchopulmonary dysplasia, grade III or IV intraventricular hemorrhage, necrotizing enterocolitis present of neuropathy present of genetic syndromes present of congenital gastrointestinal malformations R13.19 Other dysphagia Rehabilitation Rehabilitation Intervention group: Receiving Kinesiotape concomitant with oral stimulation program Control group: Receiving oral stimulation program Feeding Progression. Timepoint: during intervention. Method of measurement: Record of the number of days since the onset of oral feeding until the achievement of independent oral feeding. Weight gain. Timepoint: before intervention and Immediately after the end of the intervention. Method of measurement: Put the baby on a digital balance and record the baby's weight to gram. Feeding proficiency. Timepoint: since the onset of oral feeding until the achievement of independent oral feeding. Method of measurement: % ml taken during the first 5 min/ml prescribed. Sucking frequency. Timepoint: since the onset of oral feeding until the achievement of independent oral feeding. Method of measurement: number of sucking per minutes. Feeding duration time. Timepoint: since the onset of oral feeding until the achievement of independent oral feeding. Method of measurement: All periods in which the infant had the nipple inside the mouth. Ahvaz University of Medical Sciences Approved 2019-05-11 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan St Ahvaz Khouzestan Iran (Islamic Republic of)