Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

Not Applicable

Active, not recruiting

• Conditions: Intervention Studies; Premature Birth of Newborn
• Interventions: Other: Direct swallowing training (DST); Other: Sham intervention; Other: Oral sensorimotor stimulation (OSMS)

• Registration Number: NCT02508571
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-27
• Primary Completion: 2020-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 189

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DST+OSMS group	Direct swallowing training (DST)	One session of DST and the other of OSMS/day, five days a week
DST group	Direct swallowing training (DST)	One session of DST and the other of sham intervention/day, five days a week
Control	Sham intervention	Two 15-minute sessions of sham intervention/day, five days a week
DST group	Sham intervention	One session of DST and the other of sham intervention/day, five days a week
DST+OSMS group	Oral sensorimotor stimulation (OSMS)	One session of DST and the other of OSMS/day, five days a week

Primary Outcome Measures

Name	Time	Method
Days from start to independent oral feeding	From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Overall transfer	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 taken/volume prescribed
Volume loss	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 of milk spilled from the lips as a percentage of the total milk transferred
Bayley Scales of Infant and Toddler Development, Third Edition	Corrected age 18-24 months	* 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
Days from start to complete full oral feeding	From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks	complete full oral feeding : 2 days in a row without any adverse events The first successful day)
Rate of transfer	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%	mL/min volume of milk consumed relative to the duration of the oral Feeding session
Neonatal Oral Motor Assessment Scale (NOMAS)	Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention)	* comprehensive description of the infant's feeding patterns; * identify normal oral-motor patterns and to differentiate disorganized from dysfunctional patterns
Days from start to first full oral feeding	From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks	first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects
Proficiency	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 taken at 5 min/volume prescribed
Korean Developmental Screening Test	postnatal age 48±3 months	* 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.
Strengths and Difficulties Questionnaire	postnatal age 48±3 months	* 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
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)	postnatal age 48±3 months	* 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
Length of hospital stay	From date of admission until the date of discharge, through study completion, expected average days of 3 month	Length of hospital stay
Korean version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)	postnatal age 36±2 months	-a simple screening test for language development
Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth edition.	aged 4:00~4:11 years	* 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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of