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IRCT20200908048663N1 IRCT 2020-11-21 Ahvaz University of Medical Sciences Investigation of the effectiveness of Premature Infant Oral Motor Intervention on feeding performance of infants admitted to the NICU Investigation of the effectiveness of Premature Infant Oral Motor Intervention on feeding performance of infants admitted to the NICU 2020-11-11 anticipated 20 Complete https://irct.ir/trial/51987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is simple and using the https://www.randomizer.org site, Blinding description: Infants' mothers and an individual other than the researcher. The intervention is performed by the principal researcher and the evaluations are performed by an individual other than the researcher. In this study, the outcome evaluator does not know about the grouping of infants. N/A Dysphagia in premature infants. Intervention 1: Intervention group: 5 Minute massage in and around the mouth using a PIOMI protocol, once a day for seven days. Intervention 2: Control group: Receiving routine medical and nursing services. They do not receive any speech therapy intervention. 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 There 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 Rezvan Isazadeh
Golestan St
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3222 2818 Isazadeh.r@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Born with a gestational age of 29-32 weeks The birth weight is between 1000 to 2000 grams Physiological stability at the time of receiving oral stimulations 203 days 224 days Both Existence of chronic medical complications Existence of congenital anomalies(eg, heart, oral, etc) Existence of Necrotizing enter colitis(NEC), Existence of a brain injury (including intra-ventricular hemorrhage greater than grade 1) Existence of history of prenatal illicit drug exposure Receiving assistive ventilation (other than high-flow nasal cannula) R13.19 Other dysphagia Rehabilitation Rehabilitation Intervention group: 5 Minute massage in and around the mouth using a PIOMI protocol, once a day for seven days Control group: Receiving routine medical and nursing services. They do not receive any speech therapy intervention The Early feeding skills (EFS) assessment instrument score in preterm infants. Timepoint: At the time of the first oral feeding, the time of discharge and one week after discharge. Method of measurement: The Early feeding skills (EFS) assessment instrument in preterm infants (This checklist contains 26 items that each item can score 1, 2, or 3). 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. The transition time from gavage to independent oral feeding. Timepoint: Daily. Method of measurement: Record the number of days since the onset of gavage feeding until the achievement of independent oral feeding. Maintenance. Timepoint: One week after discharge from the hospital. Method of measurement: The Early Feeding Skills (EFS) Assessment instrument in preterm infants. Length of hospital stay. Timepoint: Daily. Method of measurement: Record the number of days from the time the infant is admitted to the NICU until discharge. Weight gain. Timepoint: At the time of enrollment, the first oral feeding, independent oral feeding, and the time of discharge from the hospital. Method of measurement: Put the infant on a digital balance and record the infant's weight to gram. Feeding proficiency. Timepoint: From the initiation of oral feeding to the time of hospital discharge. Method of measurement: % ml taken during the first 5 min/ml prescribed. Sucking frequency. Timepoint: From the initiation of oral feeding to the time of hospital discharge. Method of measurement: Number of sucking per minutes. Ahvaz University of Medical Sciences Approved 2019-07-06 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Golestan St Ahvaz Khouzestan Iran (Islamic Republic of)