Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

NCT02508571 | Completed Results DMC

• 1 other identifier: 1401139552
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth of Newborn; Intervention Studies

Keywords

Infant, Premature; Intervention Studies; Bottle feeding

Outcome Measures

Primary Outcomes (1)

• Days From Start to Independent Oral Feeding

  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)

  From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks

Secondary Outcomes (14)

• 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%

Study Arms (3)

Control

SHAM COMPARATOR

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

Other: Sham intervention

DST group

EXPERIMENTAL

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

Other: Direct swallowing training (DST); Other: Sham intervention

DST+OSMS group

EXPERIMENTAL

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

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

Interventions

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.

DST group; DST+OSMS group

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.

DST+OSMS group

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.

Control; DST group

Eligibility Criteria

• Age: 22 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc
• Gastrointestinal complications
• Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

• 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.

  PMID: 22404221 BACKGROUND

• 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.

  PMID: 12183719 BACKGROUND

• 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.

  PMID: 34281934 RESULT

MeSH Terms

Conditions

Premature Birth; Bottle Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr. Ee-Kyung Kim
• Organization: Department of Pediatrics, Seoul National University College of Medicine

kimek@snu.ac.kr

82-2-2072-3628

Study Officials

• Ee-kyung Kim

  Seoun National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation is concealed from all investigators, nurses, doctors, and parents, with the sole exception of the occupational therapists, who provided the interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 27, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2024
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Locations

KR (1)