Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

March 15, 2025 updated by: Ee-Kyung Kim, Seoul National University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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%
% 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%
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)
  • 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)
Bayley Scales of Infant and Toddler Development, Third Edition
Time Frame: 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
Corrected age 18-24 months
Korean Developmental Screening Test
Time Frame: 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.
postnatal age 48±3 months
Strengths and Difficulties Questionnaire
Time Frame: 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
postnatal age 48±3 months
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
Time Frame: 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
postnatal age 48±3 months
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
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
Time Frame: 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)
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%
% 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%
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%
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
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 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%
Length of Hospital Stay
Time Frame: From date of admission until the date of discharge, through study completion, expected average days of 3 month
Length of hospital stay
From date of admission until the date of discharge, through study completion, expected average days of 3 month
Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)
Time Frame: postnatal age 36±2 months
-a simple screening test for language development
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
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ee-kyung Kim, Seoun National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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