Clinical trial NCT02508571: Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
Official title: The Effects of Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth of Newborn
Intervention Studies
Keywords: Infant, Premature
Intervention Studies
Bottle feeding
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 189
Sex: ALL
Minimum age (years): 22
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Days From Start to Independent Oral Feeding
timeFrame: From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks
Secondary outcomes:
measure: Days From Start to First Full Oral Feeding
timeFrame: From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks
measure: Days From Start to Complete Full Oral Feeding
timeFrame: From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks
measure: Overall Transfer
timeFrame: 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%
measure: Proficiency
timeFrame: 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%
measure: Rate of Transfer
timeFrame: 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%
measure: Volume Loss
timeFrame: 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%
measure: Neonatal Oral Motor Assessment Scale (NOMAS)
timeFrame: Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention)
measure: Length of Hospital Stay
timeFrame: From date of admission until the date of discharge, through study completion, expected average days of 3 month
measure: Bayley Scales of Infant and Toddler Development, Third Edition
timeFrame: Corrected age 18-24 months
measure: Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)
timeFrame: postnatal age 36±2 months
measure: Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition.
timeFrame: aged 4:00~4:11 years
measure: Korean Developmental Screening Test
timeFrame: postnatal age 48±3 months
measure: Strengths and Difficulties Questionnaire
timeFrame: postnatal age 48±3 months
measure: Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
timeFrame: postnatal age 48±3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoun National University Hospital
name: Ee-kyung Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lau C, Smith EO. Interventions to improve the oral feeding performance of preterm infants. Acta Paediatr. 2012 Jul;101(7):e269-74. doi: 10.1111/j.1651-2227.2012.02662.x. Epub 2012 Apr 5.
citation: Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.
citation: Heo JS, Kim EK, Kim SY, Song IG, Yoon YM, Cho H, Lee ES, Shin SH, Oh BM, Shin HI, Kim HS. Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):166-173. doi: 10.1136/archdischild-2021-321945. Epub 2021 Jul 19.