Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Birth of Newborn; Intervention Studies
• Intervention / Treatment: Other: Sham intervention; Other: Direct swallowing training (DST); Other: Oral sensorimotor stimulation (OSMS)

• Study Type: Interventional
• Enrollment (Estimated): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; Two 15-minute sessions of sham intervention/day, five days a week	Other: Sham intervention; 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.
Experimental: DST group; One session of DST and the other of sham intervention/day, five days a week	Other: Sham intervention; 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.; Other: Direct swallowing training (DST); 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.
Experimental: DST+OSMS group; One session of DST and the other of OSMS/day, five days a week	Other: Direct swallowing training (DST); 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.; Other: Oral sensorimotor stimulation (OSMS); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Ee-kyung Kim, Seoun National University Hospital

Publications and helpful links

General Publications

• Lau C, Smith EO. Interventions to improve the oral feeding performance of preterm infants. Acta Paediatr. 2012 Jul;101(7):e269-74. doi: 10.1111/j.1651-2227.2012.02662.x. Epub 2012 Apr 5.
• Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731. Erratum In: J Pediatr 2002 Nov;141(5):743.
• Heo JS, Kim EK, Kim SY, Song IG, Yoon YM, Cho H, Lee ES, Shin SH, Oh BM, Shin HI, Kim HS. Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):166-173. doi: 10.1136/archdischild-2021-321945. Epub 2021 Jul 19.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2020
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimated): July 27, 2015

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Infant, Premature; Intervention Studies; Bottle feeding
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 1401139552

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No