Premature Birth of NewbornNCT02508571
Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
A study testing Direct swallowing training (DST) and Oral sensorimotor stimulation (OSMS) in people with Premature Birth of Newborn and Intervention Studies, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 22 to 31 weeks
- Conditions the study is for
- Premature Birth of Newborn, Intervention Studies
- What is being tested?
- Direct swallowing training (DST) and Oral sensorimotor stimulation (OSMS)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc
- Gastrointestinal complications
- Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Premature Birth of Newborn, Intervention Studies
- Being tested
- Direct swallowing training (DST), Oral sensorimotor stimulation (OSMS), Sham intervention
- Keywords
- Infant, Premature, Intervention Studies, Bottle feeding
- Medical subject headings
- Premature Birth, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct swallowing training (DST)Other
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)Other
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Two 15-minute sessions of sham intervention/day, five days a week Receives: Other: Sham intervention |
| DST group | Experimental | One session of DST and the other of sham intervention/day, five days a week Receives: Other: Direct swallowing training (DST); Other: Sham intervention |
| DST+OSMS group | Experimental | One session of DST and the other of OSMS/day, five days a week Receives: Other: Direct swallowing training (DST); Other: Oral sensorimotor stimulation (OSMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks
Secondary outcomes (14)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Corrected age 18-24 months
Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)
-a simple screening test for language development
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: postnatal age 48±3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2020
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ee-Kyung Kim, Seoul National University Hospital
- Investigators
- Ee-kyung Kim, Principal investigator, Seoun National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508571
- Sponsor's protocol ID
- 1401139552
- Status last verified
- Mar 2025
- First submitted
- 23 Jul 2015
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22404221Fucile 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.
PubMed 12183719Heo 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.
PubMed 34281934
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
- ClinicalTrials.gov ID
- NCT02508571
- Acronym / sponsor ID
- 1401139552
- Conditions
- Premature Birth of Newborn, Intervention Studies
- Keywords
- Infant, Premature, Intervention Studies, Bottle feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Sham interventionTwo 15-minute sessions of sham intervention/day, five days a week |
| DST group | Experimental | Other: Direct swallowing training (DST), Other: Sham interventionOne session of DST and the other of sham intervention/day, five days a week |
| DST+OSMS group | Experimental | Other: Direct swallowing training (DST), Other: Oral sensorimotor stimulation (OSMS)One session of DST and the other of OSMS/day, five days a week |
Who may qualify
- Ages
- 22 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc
- Gastrointestinal complications
- Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | DST group, DST+OSMS group |
| 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. | Other | DST+OSMS group |
| Sham interventionThe 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 | Control, DST group |
Primary outcome
Days From Start to Independent Oral Feeding
Time frame: 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)
14 secondary outcomes
Days From Start to First Full Oral Feeding
Time frame: 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
Time frame: From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks
Overall Transfer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Corrected age 18-24 months
Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)
Time frame: postnatal age 36±2 months
Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition.
Time frame: aged 4:00~4:11 years
Korean Developmental Screening Test
Time frame: postnatal age 48±3 months
Strengths and Difficulties Questionnaire
Time frame: postnatal age 48±3 months
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
Time frame: postnatal age 48±3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22404221Lau 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.
- Background: PubMed 12183719Fucile 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.
- Results publication: PubMed 34281934Heo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ee-kyung Kim principal investigator
Seoun National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct swallowing training (DST) and Oral sensorimotor stimulation (OSMS) in people with Premature Birth of Newborn and Intervention Studies, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days From Start to Independent Oral Feeding (time frame: From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508571, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.