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IRCT20180611040062N1 IRCT 2018-10-17 Tehran University of Medical Sciences The investigation effectiveness of cue-based feeding in Comparison with the traditional approach in preterm infant in neonatal intensive care unit ندارد The investigation effectiveness of cue-based feeding in Comparison with the traditional approach in preterm infant in neonatal intensive care unit 2018-06-21 anticipated 40 Complete https://irct.ir/trial/31960 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization, Blinding description: infant is particpant who dont have aware. N/A preterm infant. Intervention 1: Intervention group: Initially, infants will be evaluated 15 minutes before feeding by the oral feeding readiness assessment scale. If infant receive a score of more than 30, they will be prepared for oral feeding and, also will be begin oral feeding by a neonatal specialist diagnosis, and will use a Early feeding skill scale to get a profile of the infant's early feeding skills.When neonates reached 32 PMA no longer received mechanical ventilation, and tolerated full enteral feedings, physicians ordered assessment of the infants’ readiness for oral feedings during each scheduled care time, typically every 3 hours. At morning to afternoon, speech-language pathology reviewed infants’ scores on the Oral Feeding Readiness Scale. When infants achieved scores of 4 or 5 at 50% or more of their feeding times, health care providers ordered to begin cue-based oral feedings Infants were offered oral feedings each time their readiness scores were 4 or 5. Speech-language pathology continuously evaluated the quality of oral feedings for preterm infants on the Oral Feeding Quality Scale. An oral feeding was discontinued if the infant demonstrated two disengagement or distress cues (e.g., behaviors scored as 0 or 1 on the scale, such as falls asleep,nasal flaring, arching, or an uncoordinated suck– swallow–breathe pattern that resulted in bradycardia or oxygen desaturation). Each oral feeding could last up to 30 minutes, at which time the remaining milk was gavage fed. Infants continued on the cue-based feeding protocol until they were able to take their prescribed volume orally at each feeding.However, if the infant receives less than 30 scores in the assessment of oral feeding readiness, it is not ready for oral feeding. According to oral infant's skills, interventions such as oral non-nutritional sucking, skin to skin contact will be do before feeding with the tube at the time when the infant reaches to oral feeding. Intervention 2: Control group: Initially, infants will be evaluated 15 minutes before feeding by the oral feeding readiness assessment scale. If infant receive a score of more than 30, they will be prepared for oral feeding and, also will be begin oral feeding by a neonatal specialist diagnosis, and will use a Early feeding skill scale to get a profile of the infant's early feeding skills thanFeedings are begun on a timed or scheduled basis without regard to infant status. Infants are awakened from sleep to feed. Successful feeding is measured by volume intake, regardless of infant behaviors. 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 I dont have time
public farideh kamran
دانشکده توانبخشی
Tehran Iran (Islamic Republic of) 1563663313 +98 21 8670 5503 f-kamran@razi.tums.ac.ir Tehran University of Medical Sciences scientific farideh kamran
دانشکده توانبخشی
tehran Iran (Islamic Republic of) 1563663313 +98 21 7768 4941 f-kamran@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Preterm infants 34 week and less than 34 weeks’ gestational age at birth and Apgar score 3 or more in first one minutes and 5 or more in the five minutes Infants that don’t have neurological disorders, gastrointestinal disorders, or major congenital anomalies respiratory, cardio conditions be stable Infant don’t able to oral feeding 182 days 238 days Both Family’ loss of interest to continue in the study Unstable condition of the infant Remove the infant from the study in case of weight loss and increase the severity of the infant's problem Rehabilitation Rehabilitation Intervention group: Initially, infants will be evaluated 15 minutes before feeding by the oral feeding readiness assessment scale. If infant receive a score of more than 30, they will be prepared for oral feeding and, also will be begin oral feeding by a neonatal specialist diagnosis, and will use a Early feeding skill scale to get a profile of the infant's early feeding skills.When neonates reached 32 PMA no longer received mechanical ventilation, and tolerated full enteral feedings, physicians ordered assessment of the infants’ readiness for oral feedings during each scheduled care time, typically every 3 hours. At morning to afternoon, speech-language pathology reviewed infants’ scores on the Oral Feeding Readiness Scale. When infants achieved scores of 4 or 5 at 50% or more of their feeding times, health care providers ordered to begin cue-based oral feedings Infants were offered oral feedings each time their readiness scores were 4 or 5. Speech-language pathology continuously evaluated the quality of oral feedings for preterm infants on the Oral Feeding Quality Scale. An oral feeding was discontinued if the infant demonstrated two disengagement or distress cues (e.g., behaviors scored as 0 or 1 on the scale, such as falls asleep,nasal flaring, arching, or an uncoordinated suck– swallow–breathe pattern that resulted in bradycardia or oxygen desaturation). Each oral feeding could last up to 30 minutes, at which time the remaining milk was gavage fed. Infants continued on the cue-based feeding protocol until they were able to take their prescribed volume orally at each feeding.However, if the infant receives less than 30 scores in the assessment of oral feeding readiness, it is not ready for oral feeding. According to oral infant's skills, interventions such as oral non-nutritional sucking, skin to skin contact will be do before feeding with the tube at the time when the infant reaches to oral feeding. Control group: Initially, infants will be evaluated 15 minutes before feeding by the oral feeding readiness assessment scale. If infant receive a score of more than 30, they will be prepared for oral feeding and, also will be begin oral feeding by a neonatal specialist diagnosis, and will use a Early feeding skill scale to get a profile of the infant's early feeding skills thanFeedings are begun on a timed or scheduled basis without regard to infant status. Infants are awakened from sleep to feed. Successful feeding is measured by volume intake, regardless of infant behaviors Age of oral feeding start. Timepoint: during intervention. Method of measurement: number of day. Duration of full oral feeding. Timepoint: after intervention (discharge). Method of measurement: number of day. Weight. Timepoint: before intervention. Method of measurement: balance. The assessment of the infant’s oral feeding readiness. Timepoint: before intervention/start oral feeding day/ full oral feeding day/ discharge day. Method of measurement: Readiness assessment Scale. Early feeding skills. Timepoint: start oral feeding day/ full oral feeding day/ discharge day. Method of measurement: Early feeding skill scale. Duration of hospital admission. Timepoint: after intervention( discharge day). Method of measurement: day. Tehran University of Medical Sciences Approved 2018-06-21 ethics committee of Tehran university of medical science enqelab Ave,shemron, school of rehabilitation Tehran Tehran Iran (Islamic Republic of)