N/A
Completed N=189
Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
Premature Birth of Newborn · Intervention Studies
Source: ClinicalTrials.gov NCT02508571 ↗
Enrolled (actual)
189
Serious AEs
0.5%
Results posted
Apr 2025
Primary outcomePrimary: Days From Start to Independent Oral Feeding — 21.1; 17.2; 14.8 days
Summary
This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days From Start to Independent Oral Feeding |
21.1; 17.2; 14.8 | — |
| SECONDARY Days From Start to First Full Oral Feeding |
— | — |
| SECONDARY Days From Start to Complete Full Oral Feeding |
— | — |
| SECONDARY Overall Transfer |
— | — |
| SECONDARY Proficiency |
— | — |
| SECONDARY Rate of Transfer |
— | — |
| SECONDARY Volume Loss |
— | — |
| SECONDARY Neonatal Oral Motor Assessment Scale (NOMAS) |
— | — |
| SECONDARY Length of Hospital Stay |
— | — |
| SECONDARY Bayley Scales of Infant and Toddler Development, Third Edition |
— | — |
| SECONDARY Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI) |
— | — |
| SECONDARY Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition. |
— | — |
| SECONDARY Korean Developmental Screening Test |
— | — |
| SECONDARY Strengths and Difficulties Questionnaire |
— | — |
| SECONDARY Behavioral Pediatrics Feeding Assessment Scale (BPFAS) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02508571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.