Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

NACompletedINTERVENTIONAL
Enrollment

189

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

September 30, 2020

Study Completion Date

September 30, 2024

Conditions
Premature Birth of NewbornIntervention Studies
Interventions
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.

Trial Locations (1)

Unknown

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Seoul National University Hospital

OTHER

NCT02508571 - Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants | Biotech Hunter | Biotech Hunter