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Completed

NCT Number: NCT02508571

Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

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

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Key information

Conditions

Premature Birth of Newborn Behavior Bottle Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Intervention Studies Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

22 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct swallowing training (DST)

Other

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.

Oral sensorimotor stimulation (OSMS)

Other

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.

Sham intervention

Other

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.

Primary outcomes

  1. 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

  1. Days From Start to First Full Oral Feeding

    Time frame: From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks

    first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects

  2. Days From Start to Complete Full Oral Feeding

    Time frame: From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks

    complete full oral feeding : 2 days in a row without any adverse events The first successful day)

  3. Overall Transfer

    Time frame: 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 taken/volume prescribed

  4. Proficiency

    Time frame: 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 taken at 5 min/volume prescribed

  5. Rate of Transfer

    Time frame: 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%

    mL/min volume of milk consumed relative to the duration of the oral Feeding session

  6. Volume Loss

    Time frame: 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 of milk spilled from the lips as a percentage of the total milk transferred

  7. Neonatal Oral Motor Assessment Scale (NOMAS)

    Time frame: Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention)

    • comprehensive description of the infant's feeding patterns
    • identify normal oral-motor patterns and to differentiate disorganized from dysfunctional patterns

  8. Length of Hospital Stay

    Time frame: From date of admission until the date of discharge, through study completion, expected average days of 3 month

    Length of hospital stay

  9. Bayley Scales of Infant and Toddler Development, Third Edition

    Time frame: Corrected age 18-24 months

    • an individually administered instrument designed to assess the developmental functioning of infants, toddlers, and young children.
    • cognitive scale, motor scale (gross motor, fine motor), language scale (receptive communication, expressive communication)
    • subtest total raw scores & scaled scores / composite scores /percentile ranks/ confidence intervals
    • Total raw score range (min~max) : cognitive (0~91), receptive communication (0~49), expressive communication (0~48), fine motor (0~66), gross motor (0~72)
    • Higher scores mean better outcomes

  10. Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)

    Time frame: postnatal age 36±2 months

    -a simple screening test for language development

  11. Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition.

    Time frame: aged 4:00~4:11 years

    • An innovative measure of cognitive development and an intelligence test for preschoolers and young children
    • Primary index scales> verbal comprehension, visual spatial, fluid reasoning, working memory, processing speed ==> Full scale IQ
    • Ancillary index scales > vocabulary acquisition
    • scaled score, composite score, percentile rank, CI
    • Range of Full scale IQ : min (40) ~ max (160)
    • Higher scores mean better outcomes.

  12. Korean Developmental Screening Test

    Time frame: postnatal age 48±3 months

    • A fill-up questionnaire to be answered by parents so as to determine who experience developmental problems
    • Domains: gross motor, fine motor, language, cognition, sociality, self-care
    • Score range of each domain : min (0) ~ max (24)
    • Higher scores mean better outcomes.

  13. Strengths and Difficulties Questionnaire

    Time frame: postnatal age 48±3 months

    • a brief behavioural screening questionnaire
    • 5 subscales: Emotional problems scale, Conduct problems scale, Hyperactivity scale, Peer problems scale, Prosocial scale (score range of each scale : 0-10)
    • total difficulties score : summing scores from all the scales except the prosocial scale (score range : 0-40)
    • Lower scores mean better outcomes for the all scales except the prosocial scale

  14. Behavioral Pediatrics Feeding Assessment Scale (BPFAS)

    Time frame: postnatal age 48±3 months

    • A comprehensive and widely used measure of behavioral and skill-based feeding problems
    • It consists of 35 questions: 25 related to child eating, and 10 related to parent feeding behaviors.
    • Parents answer each question on a five-point Likert scale, then indicate whether they perceive that behavior to be problematic or not.
    • Child an parent frequency scores : from the Likert scales (score range : min 35 ~ max 175)
    • Child and parent problem scores : from the yes/no questions

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2024
First posted
Jul 27, 2015
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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