Trial Outcomes & Findings for Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants (NCT NCT02508571)
NCT ID: NCT02508571
Last Updated: 2025-04-03
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
189 participants
Primary outcome timeframe
From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks
Results posted on
2025-04-03
Participant Flow
Participants were recruited from the neonatal intensive care unit of Seoul National University Children's Hospital between July 2015 and July 2020. Infants were enrolled if they were (1) born before 32 weeks' gestation; (2) receiving full tube feeding (≥120 mL/kg/day); (3) weaned from nasal continuous positive airway pressure (NCPAP) before 33 weeks' postmenstrual age (PMA); and (4) 'feeders and growers'.
Participant milestones
| Measure |
Control
Two 15-minute sessions of sham intervention/day, five days a week
Sham intervention: 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.
|
DST Group
One session of DST and the other of sham intervention/day, five days a week
Direct swallowing training (DST): 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.
Sham intervention: 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.
|
DST+OSMS Group
One session of DST and the other of OSMS/day, five days a week
Direct swallowing training (DST): 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): 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
61
|
|
Overall Study
COMPLETED
|
63
|
63
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=64 Participants
Two 15-minute sessions of sham intervention/day, five days a week
Sham intervention: 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.
|
DST Group
n=64 Participants
One session of DST and the other of sham intervention/day, five days a week
Direct swallowing training (DST): 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.
Sham intervention: 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.
|
DST+OSMS Group
n=61 Participants
One session of DST and the other of OSMS/day, five days a week
Direct swallowing training (DST): 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): 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.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 weeks
STANDARD_DEVIATION 1 • n=64 Participants
|
29 weeks
STANDARD_DEVIATION 1 • n=64 Participants
|
29 weeks
STANDARD_DEVIATION 2 • n=61 Participants
|
29 weeks
STANDARD_DEVIATION 1 • n=189 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=64 Participants
|
30 Participants
n=64 Participants
|
28 Participants
n=61 Participants
|
89 Participants
n=189 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=64 Participants
|
34 Participants
n=64 Participants
|
33 Participants
n=61 Participants
|
100 Participants
n=189 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
64 participants
n=64 Participants
|
64 participants
n=64 Participants
|
61 participants
n=61 Participants
|
189 participants
n=189 Participants
|
PRIMARY outcome
Timeframe: From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeksDays 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)
Outcome measures
| Measure |
Control
n=63 Participants
Two 15-minute sessions of sham intervention/day, five days a week
Sham intervention: 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.
|
DST Group
n=63 Participants
One session of DST and the other of sham intervention/day, five days a week
Direct swallowing training (DST): 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.
Sham intervention: 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.
|
DST+OSMS Group
n=60 Participants
One session of DST and the other of OSMS/day, five days a week
Direct swallowing training (DST): 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): 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.
|
|---|---|---|---|
|
Days From Start to Independent Oral Feeding
|
21.1 days
Standard Deviation 15.3
|
17.2 days
Standard Deviation 9.9
|
14.8 days
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeksfirst full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weekscomplete full oral feeding : 2 days in a row without any adverse events The first successful day)
Outcome measures
Outcome data not reported
SECONDARY outcome
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%% volume taken/volume prescribed
Outcome measures
Outcome data not reported
SECONDARY outcome
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%% volume taken at 5 min/volume prescribed
Outcome measures
Outcome data not reported
SECONDARY outcome
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%mL/min volume of milk consumed relative to the duration of the oral Feeding session
Outcome measures
Outcome data not reported
SECONDARY outcome
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%% volume of milk spilled from the lips as a percentage of the total milk transferred
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of admission until the date of discharge, through study completion, expected average days of 3 monthLength of hospital stay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: postnatal age 36±2 months-a simple screening test for language development
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
DST Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
DST+OSMS Group
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Control
n=64 participants at risk
Two 15-minute sessions of sham intervention/day, five days a week
Sham intervention: 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.
|
DST Group
n=64 participants at risk
One session of DST and the other of sham intervention/day, five days a week
Direct swallowing training (DST): 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.
Sham intervention: 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.
|
DST+OSMS Group
n=61 participants at risk
One session of DST and the other of OSMS/day, five days a week
Direct swallowing training (DST): 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): 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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Death
|
0.00%
0/64 • during the period in which the intervention was applied, an average of 18 days
|
0.00%
0/64 • during the period in which the intervention was applied, an average of 18 days
|
1.6%
1/61 • during the period in which the intervention was applied, an average of 18 days
|
Other adverse events
| Measure |
Control
n=64 participants at risk
Two 15-minute sessions of sham intervention/day, five days a week
Sham intervention: 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.
|
DST Group
n=64 participants at risk
One session of DST and the other of sham intervention/day, five days a week
Direct swallowing training (DST): 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.
Sham intervention: 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.
|
DST+OSMS Group
n=61 participants at risk
One session of DST and the other of OSMS/day, five days a week
Direct swallowing training (DST): 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): 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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
3.1%
2/64 • Number of events 3 • during the period in which the intervention was applied, an average of 18 days
|
1.6%
1/64 • Number of events 4 • during the period in which the intervention was applied, an average of 18 days
|
1.6%
1/61 • Number of events 1 • during the period in which the intervention was applied, an average of 18 days
|
|
Respiratory, thoracic and mediastinal disorders
Bradycardia
|
7.8%
5/64 • Number of events 5 • during the period in which the intervention was applied, an average of 18 days
|
6.2%
4/64 • Number of events 4 • during the period in which the intervention was applied, an average of 18 days
|
4.9%
3/61 • Number of events 5 • during the period in which the intervention was applied, an average of 18 days
|
|
Respiratory, thoracic and mediastinal disorders
desaturation
|
9.4%
6/64 • Number of events 13 • during the period in which the intervention was applied, an average of 18 days
|
6.2%
4/64 • Number of events 5 • during the period in which the intervention was applied, an average of 18 days
|
3.3%
2/61 • Number of events 4 • during the period in which the intervention was applied, an average of 18 days
|
Additional Information
Dr. Ee-Kyung Kim
Department of Pediatrics, Seoul National University College of Medicine
Phone: 82-2-2072-3628
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place