Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

Premature Birth of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02508571
• Other study ID #: 1401139552
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 189
• Est. completion date: June 2026
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Weeks to 31 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Intervention Studies
• Premature Birth
• Premature Birth of Newborn

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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%
Secondary	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%
Secondary	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%
Secondary	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%
Secondary	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)
Secondary	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
Secondary	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
Secondary	Korean version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)	-a simple screening test for language development	postnatal age 36±2 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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