CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 189 enrolled
Drug / intervention
Direct swallowing training (DST) +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02508571
NCT02508571N/ACompleted

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

Seoul National University Hospital·interventional·Posted Jul 27, 2015·Updated Apr 3, 2025

In Brief

A clinical study evaluating Direct swallowing training (DST), Oral sensorimotor stimulation (OSMS), and 1 other intervention for Premature Birth of Newborn and Intervention Studies. Completed, enrolled 189 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 27, 2015
Enrollment StartJul 1, 2015
Primary CompletionSep 1, 2020
Study CompletionSep 1, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.9 years ago

Interventions

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.