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

Seoul National University Hospital1 site in 1 country189 target enrollmentJuly 2015

ConditionsPremature Birth of Newborn Intervention Studies

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premature Birth of Newborn
Sponsor: Seoul National University Hospital
Enrollment: 189
Locations: 1
Primary Endpoint: Days From Start to Independent Oral Feeding
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

September 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Ee-Kyung Kim

Clinical associate professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

Days From Start to First Full Oral Feeding(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(From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks)
Overall Transfer(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%)
Proficiency(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(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(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)(Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention))
Length of Hospital Stay(From date of admission until the date of discharge, through study completion, expected average days of 3 month)
Bayley Scales of Infant and Toddler Development, Third Edition(Corrected age 18-24 months)
Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)(postnatal age 36±2 months)
Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition.(aged 4:00~4:11 years)
Korean Developmental Screening Test(postnatal age 48±3 months)
Strengths and Difficulties Questionnaire(postnatal age 48±3 months)
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)(postnatal age 48±3 months)