Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

Study Overview
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Brief Summary
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This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.

Official Title
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The Effects of Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

Conditions
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Premature Birth of Newborn, Intervention Studies

Intervention / Treatment
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* Other: Direct swallowing training (DST)
* Other: Oral sensorimotor stimulation (OSMS)
* Other: Sham intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants : before 32+0 weeks gestation Infants who are receiving full tube feeding (more than 120 ml/kg/day) Infants who discontinue of nasal continuous positive airway pressure before postmenstrual age 33+0 weeks 'Feeders and growers' The parents of the subject voluntarily sign the informed consent Exclusion Criteria: Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc Gastrointestinal complications Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 31 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Two 15-minute sessions of sham intervention/day, five days a week | Other: Sham intervention<br>* The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.<br>|
| Experimental: DST group<br>One session of DST and the other of sham intervention/day, five days a week | Other: Direct swallowing training (DST)<br>* The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.<br>Other: Sham intervention<br>* The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.<br>|
| Experimental: DST+OSMS group<br>One session of DST and the other of OSMS/day, five days a week | Other: Direct swallowing training (DST)<br>* The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.<br>Other: Oral sensorimotor stimulation (OSMS)<br>* The OSMS consists of a 15-minute stimulation program, whereby the first 12 minutes involve stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consist of sucking on a pacifier. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days from start to independent oral feeding | Days from start to independent oral feeding (independent oral feeding, 2 days in a row with no adverse events that do not self-resolve - The first successful day) | From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days from start to first full oral feeding | first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects | From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks | 
| Days from start to complete full oral feeding | complete full oral feeding : 2 days in a row without any adverse events The first successful day) | From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks | 
| Overall transfer | % volume taken/volume prescribed | Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100% | 
| Proficiency | % volume taken at 5 min/volume prescribed | Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100% | 
| Rate of transfer | mL/min volume of milk consumed relative to the duration of the oral Feeding session | Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100% | 
| Volume loss | % volume of milk spilled from the lips as a percentage of the total milk transferred | Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100% | 
| Neonatal Oral Motor Assessment Scale (NOMAS) | comprehensive description of the infant's feeding patterns identify normal oral-motor patterns and to differentiate disorganized from dysfunctional patterns | Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention) | 
| Length of hospital stay | Length of hospital stay | From date of admission until the date of discharge, through study completion, expected average days of 3 month | 
| Bayley Scales of Infant and Toddler Development, Third Edition | an individually administered instrument designed to assess the developmental functioning of infants, toddlers, and young children. cognitive scale, motor scale (gross motor, fine motor), language scale (receptive communication, expressive communication) subtest total raw scores & scaled scores / composite scores /percentile ranks/ confidence intervals Total raw score range (min max) : cognitive (0 91), receptive communication (0 49), expressive communication (0 48), fine motor (0 66), gross motor (0 72) Higher scores mean better outcomes | Corrected age 18-24 months | 
| Korean version of MacArthur-Bates Communicative Development Inventories (K M-B CDI) | -a simple screening test for language development | postnatal age 36±2 months | 
| Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth edition. | An innovative measure of cognitive development and an intelligence test for preschoolers and young children Primary index scales> verbal comprehension, visual spatial, fluid reasoning, working memory, processing speed ==> Full scale IQ Ancillary index scales > vocabulary acquisition scaled score, composite score, percentile rank, CI Range of Full scale IQ : min (40)   max (160) Higher scores mean better outcomes. | aged 4:00 4:11 years | 
| Korean Developmental Screening Test | A fill-up questionnaire to be answered by parents so as to determine who experience developmental problems Domains: gross motor, fine motor, language, cognition, sociality, self-care Score range of each domain : min (0)   max (24) Higher scores mean better outcomes. | postnatal age 48±3 months | 
| Strengths and Difficulties Questionnaire | a brief behavioural screening questionnaire 5 subscales: Emotional problems scale, Conduct problems scale, Hyperactivity scale, Peer problems scale, Prosocial scale (score range of each scale : 0-10) total difficulties score : summing scores from all the scales except the prosocial scale (score range : 0-40) Lower scores mean better outcomes for the all scales except the prosocial scale | postnatal age 48±3 months | 
| Behavioral Pediatrics Feeding Assessment Scale (BPFAS) | A comprehensive and widely used measure of behavioral and skill-based feeding problems It consists of 35 questions: 25 related to child eating, and 10 related to parent feeding behaviors. Parents answer each question on a five-point Likert scale, then indicate whether they perceive that behavior to be problematic or not. Child an parent frequency scores : from the Likert scales (score range : min 35   max 175) Child and parent problem scores : from the yes/no questions | postnatal age 48±3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Premature, Intervention Studies, Bottle feeding