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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Two 15-minute sessions of sham intervention/day, five days a week |
|
| DST group | Experimental | One session of DST and the other of sham intervention/day, five days a week |
|
| DST+OSMS group | Experimental | One session of DST and the other of OSMS/day, five days a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Days From Start to First Full Oral Feeding | first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ee-kyung Kim | Seoun National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22404221 | Background | 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. | |
| 12183719 | 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. |
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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'.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | days | From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks |
|
during the period in which the intervention was applied, an average of 18 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ee-Kyung Kim | Department of Pediatrics, Seoul National University College of Medicine | 82-2-2072-3628 | kimek@snu.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2015 | Feb 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Allocation is concealed from all investigators, nurses, doctors, and parents, with the sole exception of the occupational therapists, who provided the interventions.
|
| 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. |
|
complete full oral feeding : 2 days in a row without any adverse events The first successful day) |
| From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks |
| Overall Transfer | % volume taken/volume prescribed | 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 | % volume taken at 5 min/volume prescribed | 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 | mL/min volume of milk consumed relative to the duration of the oral Feeding session | 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 Loss | % volume of milk spilled from the lips as a percentage of the total milk transferred | 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% |
| Neonatal Oral Motor Assessment Scale (NOMAS) |
| Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention) |
| Length of Hospital Stay | Length of hospital stay | From date of admission until the date of discharge, through study completion, expected average days of 3 month |
| Bayley Scales of Infant and Toddler Development, Third Edition |
| Corrected age 18-24 months |
| Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI) | -a simple screening test for language development | postnatal age 36±2 months |
| Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition. |
| aged 4:00~4:11 years |
| Korean Developmental Screening Test |
| postnatal age 48±3 months |
| Strengths and Difficulties Questionnaire |
| postnatal age 48±3 months |
| Behavioral Pediatrics Feeding Assessment Scale (BPFAS) |
| postnatal age 48±3 months |
| 34281934 | Result | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
| OG002 | 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. |
|
|
| Secondary | Days From Start to First Full Oral Feeding | first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects | Not Posted | From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks | Participants |
| Secondary | Days From Start to Complete Full Oral Feeding | complete full oral feeding : 2 days in a row without any adverse events The first successful day) | Not Posted | From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks | Participants |
| Secondary | Overall Transfer | % volume taken/volume prescribed | Not Posted | 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% | Participants |
| Secondary | Proficiency | % volume taken at 5 min/volume prescribed | Not Posted | 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% | Participants |
| Secondary | Rate of Transfer | mL/min volume of milk consumed relative to the duration of the oral Feeding session | Not Posted | 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% | Participants |
| Secondary | Volume Loss | % volume of milk spilled from the lips as a percentage of the total milk transferred | Not Posted | 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% | Participants |
| Secondary | Neonatal Oral Motor Assessment Scale (NOMAS) |
| Not Posted | Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention) | Participants |
| Secondary | Length of Hospital Stay | Length of hospital stay | Not Posted | From date of admission until the date of discharge, through study completion, expected average days of 3 month | Participants |
| Secondary | Bayley Scales of Infant and Toddler Development, Third Edition |
| Not Posted | Corrected age 18-24 months | Participants |
| Secondary | Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI) | -a simple screening test for language development | Not Posted | postnatal age 36±2 months | Participants |
| Secondary | Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition. |
| Not Posted | aged 4:00~4:11 years | Participants |
| Secondary | Korean Developmental Screening Test |
| Not Posted | postnatal age 48±3 months | Participants |
| Secondary | Strengths and Difficulties Questionnaire |
| Not Posted | postnatal age 48±3 months | Participants |
| Secondary | Behavioral Pediatrics Feeding Assessment Scale (BPFAS) |
| Not Posted | postnatal age 48±3 months | Participants |
| 0 |
| 64 |
| 0 |
| 64 |
| 9 |
| 64 |
| EG001 | 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. | 0 | 64 | 0 | 64 | 5 | 64 |
| EG002 | 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. | 1 | 61 | 1 | 61 | 5 | 61 |
| Bradycardia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| Male |
|