Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

Seoul National University

Status: Completed

Conditions: Intervention Studies; Premature Birth of Newborn

Treatments: Other: Direct swallowing training (DST); Other: Sham intervention; Other: Oral sensorimotor stimulation (OSMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02508571

1401139552

Details and patient eligibility

About

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

Enrollment: 189 patients

Sex: All

Ages: 22 to 31 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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189 participants in 3 patient groups

Control

Sham Comparator group

Description:

Two 15-minute sessions of sham intervention/day, five days a week

Treatment:

Other: Sham intervention

DST group

Experimental group

Description:

One session of DST and the other of sham intervention/day, five days a week

Treatment:

Other: Sham intervention

Other: Direct swallowing training (DST)

DST+OSMS group

Experimental group

Description:

One session of DST and the other of OSMS/day, five days a week

Treatment:

Other: Oral sensorimotor stimulation (OSMS)

Other: Direct swallowing training (DST)