NCT02508571

Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 22 Weeks – 31 Weeks
• Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-09-01
• Completion: 2024-09-01
• First posted: 2015-07-27
• Last updated: 2025-04-03
• Results posted: 2025-04-03

Locations

1 site across 1 country: South Korea