The Effects of Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
Phase: NA
Conditions: Premature Birth of Newborn, Intervention Studies
Sponsor: Seoul National University Hospital

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 1 
 
 
[ Protocol for Clinical Trial ] 
 
 
 
 
The effects of direct swallowing training and oral sensorimotor stimulation in 
preterm infants 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2015.07 
 
NCT02508571 
 
 
 
 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 2 
 
Table of Contents 
 
1. Title of the Clinical Trial .......................................................................................................................................... 5 
2. Name and Address of the Clinical Trial Institution .......................................................................................... 5 
3. Study Period .............................................................................................................................................................. 5 
4. Objectives of the Study .......................................................................................................................................... 5 
5. Study Design .............................................................................................................................................................. 5 
6. Study Participants ..................................................................................................................................................... 5 
7. Study procedures ..................................................................................................................................................... 7 
8. Study evaluation ........................................................................................................................................................ 12 
9. Dropout ....................................................................................................................................................................... 15 
10. References ................................................................................................................................................................ 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[Clinical Trial Overview] 
 
Clinical Trial Title 
The effects of direct swallowing training and oral sensorimotor stimulation in 
preterm infants 
Objective of the 
Clinical Trial 
This study aims to evaluate whether the application of direct swallowing 
training (DST) and oral sensorimotor stimulation (OSMS) in preterm infants 
preparing for the transition from tube feeding to oral feeding shortens the 
time required for complete oral feeding and improves oral feeding skills. 
Additionally, the study will assess the long-term impact of oral feeding 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 3 
 
interventions in the neonatal intensive care unit (NICU) on developmental 
outcomes and dietary habits. 
Phase of the 
Clinical Trial 
Prospective, blind, controlled, randomized trial 
 
Clinical Trial 
Institution 
Seoul National University Hospital  
Principal 
Investigator 
Ee-Kyung Kim, Department of Pediatrics, Seoul National University College 
of Medicine 
Study Design 
single-center, prospective, open-label, controlled, randomized study 
Study 
participants 
-Gestational age at birth < 32+0 weeks 
-Eligible for respiratory support using heated humidified high-flow nasal 
cannula (HHHFNC) or equivalent, within 33+0 weeks 
-Infants who have been progressing with tube feeding at a volume of 120 
ml/kg/day or more 
-Informed consent obtained from parents or legal guardians 
Number of 
participants 
189 
Study 
methodology  
In this study, preterm infants who are receiving adequate tube feeding and 
have been discontinued from continuous positive airway pressure (CPAP) for 
at least 48 hours will be divided into three groups: 
- Control Group 
-DST Group (Direct Swallowing Training) 
-DST + OSMS Group (Direct Swallowing Training + Oral Sensorimotor 
Stimulation) 
Each group will receive its respective intervention.  
Study period 
From IRB approval date in 2015 to December 30, 2025. 
Outcomes 
1. Time from initiation of oral feeding to full oral feeding  
2. Oral feeding performance  
3. Neonatal Oral Motor Assessment Scale (NOMAS)   
4. Bayley Scales of Infant and Toddler Development, Third Edition: CA 18-
24months 
5. Korean Version of MacArthur-Bates Communicative Development 
Inventories (K M-B CDI): postnatal age 36 ± 2 months 
6. Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-
Fourth Edition: 4:0~4:11 years  
7. Korean Developmental Screening Test for Infants (K-DST) : postnatal age 
48 ± 3 months 
8. Strengths and Difficulties Questionnaire (SDQ) : postnatal age 48 ± 3 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 4 
 
months 
9. Behavioral Pediatric Feeding Assessment Scale (BPFAS) : postnatal age 48 
± 3 months 
Expected 
outcomes and 
potential impact 
It is expected that the group receiving DST will show improved oral feeding 
abilities compared to the control group. Furthermore, the combination of 
OSMS with DST is anticipated to have a synergistic effect, further enhancing 
oral feeding skills. Additionally, it is expected that interventions during the 
neonatal period will have a lasting impact on long-term development and 
feeding behaviors. 
 
 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 5 
 
1. Title of the clinical trial  
The effects of direct swallowing training and oral sensorimotor stimulation in preterm infants 
 
2. Name and Address of the Clinical Trial Institution 
Institution Name: Seoul National University Children’s Hospital 
Address: 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea 
 
3. Study period 
From IRB approval date in 2015 to December 30, 2025. 
 
4. Objectives of study 
We will observe whether the application of direct swallowing training (DST) and oral sensorimotor 
stimulation (OSMS) to preterm infants, preparing for the transition from gavage feeding to oral 
feeding, shortens the period of transition to full oral feeding and improves oral feeding ability. 
Additionally, we will evaluate the long-term impacts of oral feeding interventions in the neonatal 
intensive care unit (NICU) on development, feeding behaviors, and other related factors. 
 
5. Study Design 
single-center, prospective, open-label, controlled, randomized study 
 
6. Study participants 
 
6.1 Participants  
Preterm infants with a gestational age of less than 32+0 weeks, admitted to the NICU at Seoul 
National University Children's Hospital, who can be administered respiratory support with heated, 
humidified high-flow nasal cannula within 33+0 weeks and who have received gavage feeding of 
at least 120 ml/kg/d. 
 
6.2 Target sample size and rationale for calculation  
 
The primary objective of this study is to determine whether there is a difference in the time taken 
to reach full oral feeding, from the initiation of oral feeding, when DST and OSMS are applied to  
preterm infants preparing for the transition from gavage feeding to oral feeding. 
 
To calculate the sample size required to achieve the research objective, the following assumptions 
are made: 
 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 6 
 
(1) Level of significance (α): 0.0167 (two-tailed test). 
When comparing the control group with the DST group, the control group with the DST + OSMS 
group, and the DST group with the DST + OSMS group, there is an issue of multiple comparisons. 
To address this, Bonferroni correction is applied. The significance level used is 0.05/3 = 0.0167. 
 
(2) Group ratio: Control group : DST group : DST + OSMS group = 1 : 1 : 1. 
 
(3) Type II error (β): 0.20, maintaining a test power of 80%. 
 
(4) Primary outcome: Days from start to full oral feeding (SOF-FOF). 
 
(5) The hypothesis of the study is as follows: 
[Hypothesis 1] 
Null hypothesis: There is no difference in SOF-FOF days between the control group and the DST 
group. 
Alternative hypothesis: There is a difference in SOF-FOF days between the control group and 
the DST group. 
 
[Hypothesis 2] 
Null hypothesis: There is no difference in SOF-FOF days between the control group and the DST 
+ OSMS group. 
Alternative hypothesis: There is a difference in SOF-FOF days between the control group and 
the DST + OSMS group. 
 
[Hypothesis 3] 
Null hypothesis: There is no difference in SOF-FOF days between the DST group and the DST + 
OSMS group. 
Alternative hypothesis: There is a difference in SOF-FOF days between the DST group and the 
DST + OSMS group. 
 
(6) Sample size calculation method: The PASS program (Power Analysis and Sample Size 
software; http://www.ncss.com) will be used. 
 
Based on existing research data (16, 18), the average SOF-FOF days for each group were assumed 
as follows: Control group 20.8 days, DST group 14.6 days, and DST + OSMS group 10.0 days. The 
pooled standard deviation was calculated to be 7.19. With a significance level of 1.67% and a 
two-tailed test, the required sample size for 80% power is 56 participants per group, for a total of 
168 participants. 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 7 
 
Assuming a 10% dropout rate, the final sample size, accounting for dropouts, is 189 participants. 
 
6.3 Recruiment method for study participants 
The guardians of eligible participants will be approached to obtain their consent for participation 
in the study. Detailed information about the study will be provided to them, including its 
objectives, procedures, potential risks, and benefits. Informed consent will be obtained from the 
guardians before the preterm infants are enrolled in the study. All necessary ethical considerations 
and guidelines will be followed during the recruitment process, ensuring the confidentiality and 
protection of the participants' privacy. 
 
6.4 Inclusion and Exclusion criteria for enrolment 
6.4.1. Inclusion criteria 
(1) Preterm infants with a gestational age of less than 32+0 weeks. 
(2 )Infants currently receiving sufficient tube feeding (at least 120 ml/kg/day). 
(3) Infants who can be treated with heated, humidified high-flow nasal cannula (HFNC) within 
33+0 weeks. 
(4) Infants who only have feeding-related issues remaining, with no need for special medical 
treatment. 
(5) Infants whose parents voluntarily sign the informed consent form for participation in the 
study. 
 
6.4.2. Exclusion criteria 
(1) Infants with major congenital malformations, such as those affecting the face, central nervous 
system, gastrointestinal system, or heart. 
(2) Infants with gastrointestinal complications. 
(3) Infants with chronic medical conditions, such as Grade 3 or higher intraventricular 
hemorrhage (according to the classification by Papile et al), periventricular leukomalacia, or those 
who have undergone surgical treatment for necrotizing enterocolitis. 
 
7. Study procedures 
 
7.1 Screening 
 
Evaluation items: gestational age at birth, participant consent, assessment of inclusion/exclusion 
criteria  
 
7.2 Randomization 
In this study, eligible participants who meet all the inclusion criteria will be randomly assigned in a 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 8 
 
1:1:1 ratio to the control group, the DST group, or the DST + OSMS group. However, randomization 
will be stratified by gestational age and sex. 
 
The randomization will be done using a block randomization method with block sizes of 3 and 6, 
generated through SAS 9.2. The randomization process will be managed via the MRCC website 
(http://mrcc.snu.ac.kr) using web-based randomization. 
 
The detailed randomization procedure is as follows: 
- Study coordinators will be provided with an ID and password for randomization. 
- The study coordinators will log in to the MRCC website (http://mrcc.snu.ac.kr) and access the 
randomization screen. 
- The study coordinator will enter the participant’s basic information, test results, inclusion/exclusion 
criteria, and other relevant data, and click the confirmation button. 
- If the participant is eligible, a randomization number will appear on the screen. 
- The randomization screen will be printed, and one copy will be kept for records. 
- The study coordinator will use the assigned randomization number to prescribe the corresponding 
intervention. 
 
7.3 Intervention protocol 
 
7.3.1. Initiation  
The intervention will begin at the point when the preterm infant, who is receiving sufficient 
feeding via gavage (≥ 120 ml/kg/d), has reached a postmenstrual age (PMA) of at least 28 weeks 
and has been at least 48 hours since the removal of nasal continuous positive airway pressure 
(CPAP) therapy. 
 
7.3.2. Frequency of implementation and the duration of each intervention 
- DST group: The intervention will be administered once a day, for 15 minutes each session. 
- DST + OSMS group: Both interventions will be applied once a day. DST will be administered 
once a day for 15 minutes, and OSMS will be performed once a day for 15 minutes as well. The 
order of the interventions is not specified, so they can be done in any sequence. 
- Both groups will receive their respective interventions 5 times a week. 
 
7.3.3 Discontinuation of intervention 
The intervention will be discontinued when the infant can feed orally without requiring special 
treatment (including apnea, bradycardia, and oxygen desaturation) for two consecutive days during 
all feedings. 
- If the infant is disrupted by factors such as taking sedatives or undergoing ophthalmologic exams 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 9 
 
within 30 minutes prior to the intervention, the intervention will not be applied that day. 
- During the intervention, if any hemodynamic instability, apnea, bradycardia, or oxygen desaturation 
that does not resolve spontaneously occurs, the intervention will be stopped early. The 
intervention will only resume once the infant has stabilized and returned to a stable condition. 
 
7.3.4. Detailed method for each intervention  
Both the experimental group and the control group will continue the use of non-nutritive sucking 
through a rubber nipple and oral support during feeding, which are currently standard practices in 
the neonatal intensive care unit. 
 
7.3.4.1. Direct swallowing training (DST) 
The procedure will be carried out between feedings, lasting a total of 15 minutes.  
 
Amount administered at one time: Formula milk (or distilled water if the caregiver refuses) is given 
at 1 ml. The administration starts with 0.05 ml using a syringe, gradually increasing by 0.05 ml 
increments while checking for the presence of a swallowing reflex. Once this threshold is 
determined, the procedure will continue using that dose. The maximum volume administered will 
not exceed 0.2 ml. 
 
Administration site: The milk will be dropped onto the tongue at a level approximately where the 
soft palate and hard palate meet, specifically in the central-to-posterior region of the tongue. 
 
Interval between administrations: The procedure will be performed at 30-second intervals for a 
total of 15 minutes. 
 
7.3.4.2. Oral sensorimotor stimulation (OSMS) 
The procedure will be carried out 15-30 minutes before the tube feeding, specifically during 
behavioral stages 3-5, and the total duration will be 15 minutes. 
 
Composition 
stimulation 
Objective 
Duration 
Trigg
ering 
sucki
ng 
reflex 
Cheek 1) Place the index finger on the philtrum (the 
area above the upper lip). 
2) Gently press and apply pressure, moving 
towards the ear and then back to the corner 
of the mouth, tracing a "C" shape. 
Enhance the range 
of motion and 
strength of the 
cheeks, and improve 
lip closure. 
4 min. 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 10 
 
Curlin
g and 
pulling 
the 
upper 
and 
lower 
lips 
1) Place the index finger at the center of the 
upper lip. 
2) Continue pressing and pull downward, 
rolling the lip. 
3) Place the index finger at the center of the 
lower lip, press, and pull upward, rolling the 
lip. 
Enhance lip 
strength, range of 
motion, and lip 
closure. 
30 sec 
Upper lip 
1) Place your index finger on one side of the 
upper lip. 
2) Gently press down. 
3) Move your finger in a circular motion, 
starting from one end, passing through the 
center of the lips, and ending at the 
opposite side. 
Improvement of lip 
range of motion and 
lip closure strength. 
30 sec 
Lower lip  
1) Place your index finger on one corner of 
the lower lip.   
2) Gently press down.   
3) Move in a circular motion, starting from 
one corner, passing through the center of 
the lip, and continuing to the opposite 
corner. 
Improvement of lip 
range of motion and 
lip closure strength. 
30 sec 
Inside of the 
cheek 
1) Place your finger on the inside of the 
corner of the mouth.   
2) Gently press and move towards the 
molars, then return to the corner of the 
mouth. 
Improvement of the 
range of motion of 
the cheeks and lip 
closure. 
1 min 
Upper gums 
1) Place your finger on the center of the 
upper gums and press firmly, slowly moving 
inward inside the mouth.   
Range of tongue 
motion, swallowing 
stimulation, and 
40 sec 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 11 
 
2) Slowly return to the center. 
sucking 
improvement. 
Lower gums  1) Press your finger firmly on the center of 
the lower gum and slowly move it inward.   
2) Slowly return to the center. 
Range of tongue 
motion, swallowing 
stimulation, and 
sucking 
improvement. 
40 sec  
Side of the 
tongue 
1) Place your finger between the side of the 
tongue and the gum near the molars.   
2) Move your finger toward the center while 
pushing the tongue in the opposite direction. 
3) After pushing the tongue, immediately 
return to the cheek and stretch it as much as 
possible. 
Tongue range of 
motion and strength 
enhancement 
30 sec 
Dorsal 
surface of 
the tongue 
1) Place the index finger in the center of the 
mouth.   
2) Press against the hard palate for 3 
seconds.   
3) Place your finger on the center of the 
tongue and press down firmly.   
4) Immediately return to the center of the 
hard palate after pressing the tongue. 
Tongue range of 
motion and strength 
enhancement, 
swallowing 
stimulation, sucking 
improvement 
40 sec 
Induce 
sucking  
1) Place your finger in the center of the 
palate and gently rub it to induce sucking. 
Sucking 
improvement, velum 
activation 
3 min 
Pacifier  
1) Place the pacifier in the mouth and gently 
move it in a rhythmic motion, up/down and 
front/back. 
Sucking 
improvement, velum 
activation 
3 min. 
 
10.4.3.3 For blind study 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 12 
 
   For the blind study, all interventions are conducted with the screen in place. For the control 
group, the researcher spends time with the patient next to them while keeping the screen up 
at the same time as in the intervention group. The researcher inserts their hand into the 
incubator and spends 15 minutes without performing any interventions.  
 
8. Study evaluation  
 
8.1 Basic cllinical factors  
 
- Gestational age, birth physical measurements, sex, singleton/twin, delivery type, Apgar score, 
umbilical cord blood gas findings, birth place, pregnancy complications, use of antenatal steroids, 
presence of pathological chorioamnionitis   
- Public insurance status (general insurance vs. social assistance), marital status, parents' education 
level, parents' age, parents' occupation   
- Neonatal respiratory distress syndrome, confirmed sepsis, patent ductus arteriosus (treatment 
status), abnormal findings on brain ultrasound, necrotizing enterocolitis requiring medical treatment, 
apnea of prematurity (treatment status), timing of discontinuation of apnea medication, feeding 
intolerance (treatment status), neonatal rickets, bronchopulmonary dysplasia, duration of mechanical 
ventilation (invasive, non-invasive, supplemental oxygen)   
- Age (postnatal days, postmenstrual age) and physical measurements, feeding volume, and 
respiratory support methods at the following time points:   
  * When the initial gavage feeding starts,   
  * When the intervention begins,   
  * When the feeding volume reaches 120 ml/kg/d,   
  * When the first oral feeding begins,   
  * When the oral feeding volume reaches 50% and 100% of 120 ml/kg/day,   
  * When all feeding transitions to oral feeding, regardless of feeding-related side effects,   
  * When full oral feeding is possible without any feeding-related side effects that require special 
treatment (end of intervention),   
  * When full oral feeding is possible without any feeding-related side effects.   
- The day of birth weight recovery, duration of TPN, duration of gavage feeding, type of milk, 
period until resolution of feeding-related apnea, bradycardia, and oxygen saturation decrease after 
reaching full oral feeding.   
- Total hospitalization period, age (in postnatal days, postmenstrual age) and physical 
measurements at discharge.   
- Results of developmental assessment tests for long-term developmental evaluation in eligible 
patients for clinical purposes:   
  * Bayley Scales of Infant and Toddler Development, 3rd Edition (corrected age 18-24 months) 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 13 
 
(Indications: GA < 32 weeks or BW < 1500g)   
  * Korean version of the McArthur-Bates Communicative Development Inventory (at 36±2 
months) (Indications: GA < 32 weeks)   
* Korean Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (K-WPPSI-IV) (from 4 
years to less than 5 years of age) (Indications: GA < 29 weeks or BW < 1000g) 
 
8.2 Clinical observation factors 
 
8.2.1. Vital signs: SpO2, blood pressure, heart rate, respiratory rate  
 
8.2.2. Indicators for evaluating the patient’s condition before feeding 
 
(1) Behavioral organization states 
 
 
 
2) Feeding readiness behaviors : 
 
①Crying near scheduled feeding time 
② Increased general activity level (involving increased heart rate) 
③ Hand-to-mouth and sucking on hand 
④ sucking pacifier 
 
      (If none of 1, 2, or 3 apply, provide a pacifier, and if sucking is present, check item 4.) 
 
8.2.3. Indicators for evaluating oral feeding performance 
Data will be collected through three evaluations:   
1) The time point when oral feeding starts,   
2) The time point when oral feeding volume reaches 50% of total feeding volume,   
3) The time point when oral feeding volume reaches 100% of total feeding volume. 
 
-Overall transfer (% volume taken/volume prescribed) 
-Proficiency (% volume taken at 5 min/volume prescribed) 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 14 
 
-Rate of transfer (mL/min volume of milk consumed relative to the duration of the oral  
Feeding session) 
-Volume loss (% volume of milk spilled from the lips as a percentage of the total milk  
transferred)  
 
  8.2.4. Neonatal Oral Motor Assessment Scale (NOMAS) 
 
    Evaluation time points:   
1) Between 3-5 days after the start of oral feeding,   
2) Within 3 days after the end of the intervention. 
 
  8.2.5. Korean Developmental Screening Test for Infants and Toddlers (K-DST), Strengths and 
Difficulties Questionnaire (SDQ), Behavioral Pediatric Feeding Assessment Scale (BPFAS) 
    
    Survey time point: 48 months of age ± 3 months   
Survey method: The survey will be conducted by implementing a web-based questionnaire, 
which will be sent via email or smartphone and returned through the same method. 
 
8.3 Outcome 
 
8.3.1. Primary outcome: The period from the start of oral feeding to the time when full oral 
feeding is achieved without any feeding-related side effects requiring special treatment. 
 
8.3.2. Secondary outcomes 
- The period from the start of oral feeding to the first achievement of full oral feeding   
- The period from the start of oral feeding to the achievement of full oral feeding without any 
feeding-related side effects   
- Overall transfer, proficiency, rate of transfer, volume loss 
- length of hospital stay 
- NOMAS   
- Bayley Scales of Infant and Toddler Development (Bayley-III)   
- Korean version of the McArthur-Bates Communicative Development Inventory (K-MBCDI)   
- Korean Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI-IV)   
- Korean Developmental Screening Test for Infants and Toddlers (K-DST)   
- Strengths and Difficulties Questionnaire (SDQ)   
- Behavioral Pediatric Feeding Assessment Scale (BPFAS) 
 
8.4 Statistical analysis methods 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 15 
 
 
 8.4.1. Definition of Analysis Sets   
 
- ITT Analysis Set (Intent-to-Treat): Includes data from all pediatric patients who received at least 
one session of oral rehabilitation therapy and had at least one assessment of the outcome 
variable.   
- FAS Analysis Set (Full Analysis Set): Includes data from the ITT set, excluding patients who did 
not meet the eligibility criteria or failed to undergo the primary outcome assessment.   
- PP Analysis Set (Per-Protocol): Includes data from the ITT set, specifically from patients who 
strictly adhered to the clinical trial protocol by completing direct swallowing training or both 
direct swallowing training and sensory-motor stimulation therapy, with outcome variables 
assessed. 
This study will conduct ITT, FAS, and PP analyses, with FAS analysis being the primary approach. 
 
* Subgroup Analysis: Subgroup analysis will be performed based on gestational age, birth 
weight, and bronchopulmonary dysplasia. 
 
8.4.2 Statistical Analysis Methods  
- Statistical Software: SPSS for Windows (version 19.0)   
- Continuous Variables: Mann-Whitney U test, One-way ANOVA   
- Categorical Variables: Chi-square test, Fisher’s exact test   
- Evaluation of the Effect of Interventions on Primary and Secondary Outcomes:   
  - Two-way analysis of variance   
  - Repeated measures analysis of variance   
  - Post-hoc analysis, if necessary   
- Univariate/Multivariate Analysis: Binary and multiple logistic regression analysis   
- Unless otherwise specified, all statistical tests will be conducted at a two-sided significance 
level of 0.05. 
 
9. Drop out 
<Criteria for Clinical Trial Dropout> 
- When the guardian requests discontinuation of the clinical trial or withdraws consent for 
participation. 
- When the participant experiences respiratory deterioration during the trial period, requiring the 
use of a respiratory device beyond nasal positive pressure ventilation. 
- When the participant experiences gastrointestinal deterioration during the trial period, 
necessitating fasting for more than 48 hours. 
- When a serious adverse event occurs. 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 16 
 
 
10. References 
 
1) American Academy of Pediatrics Committee on Fetus and Newborn.Hospital discharge of the 
high-risk neonate.Pediatrics 2008;122:1119-26. 
2) Bragdon DB. A basis for the nursing management of feeding the premature infant. JOGN Nurs 
1983;12(3 Suppl):51s-7s. 
3) Gryboski JD. Suck and swallow in the premature infant. Pediatrics 1969;43:96-102. 
4) Krauss AN, Brown J, Waldman S, Gottlieb G, Auld PA. Pulmonary functionfollowing feeding in 
low-birth-weight infants. Am J Dis Child 1987;132:139-42. 
5) Lau C, Sheena HR, Shulman RJ, Schanler RJ. Oral feeding in low birth weight infants. J Pediatr 
1997;130:561-9. 
6) Bingham PM. Deprivation and dysphagia in premature infants. J Child Neurol 2009;24:743-9. 
7) Choi HW, Park HW, Kim HY, Lim GN, Koo SE, Lee BS, et al. Feeding desaturation and effects of 
orocutaneous stimulation in extremely low birth weight infants. J Korean SocNeonatol 2010;17:193-
200. 
8) Kim HY, Bang KS.Effects of an oral stimulation program on the transition from tube to bottle 
feeding in premature infants.J Korean AcadFundamNurs 2011;18:160-7. 
9) Lau C, Sheena HR, Shulman RJ, Schanler RJ. Oral feeding in low birth weight infants. J Pediatr 
1997;130:561-9. 
10) Lamm NC, De Felice A, Cargan A. Effect of tactile stimulation on lingual motor function in 
pediatric lingual dysphagia. Dysphagia 2005;20:311-24 
11) Dodrill P, McMahao S, Donovan T, Cleghorn G. Current management of transitional feeding 
issues in preterm neonates born in Queensland, Australia. Early Hum Dev 2008;84:637-43.  
12) Fucile S, Gisel EG, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in 
preterm infants. J Pediatr 2002;141:230-6. 
13) Pinelli J, Symington AJ. Non-nutritive sucking for promoting physiologic stability and nutrition 
in preterm infants (review). Cochrane Database Syst Rev 2005;19:CD001071. 
14) Fucile S, Gisel EG, Lau C. Effect of an oral stimulation program on sucking skill maturation of 
preterm infants. Dev Med Child Neurol 2005;47:158-62. 
15) Boiron M, DaNobrega L, Roux S, Henrot A, Saliba E. Effects of oral stimulation and oral support 
on non-nutritive sucking and feeding performance in preterm infants. Dev Med Child Neurol 
2007;49:439-44. 
16) Fucile S, Gisel EG, Mcfarland DH, Lau C. Oral and non-oral sensorimotor interventions enhance 
oral feeding performance in preterm infants. Dev Med Child Neurol 2011;53:829-35. 
17) Fucile S, Mcfarland DH, Gisel EG, Lau C. Oral and nonoral sensorimotor interventions facilitate 
suck-swallow-respiration functions and their coordination in preterm infants. Early Hum Dev 
2012;88:345-50. 

Protocol_DST and OSMS_oral feeding performance             
Investigator-Initiated Trial                                                                 17 
 
18) Lau C, Smith EO. Interventions to improve the oral feeding performance of preterm 
infants.ActaPaediatrica 2012;101:e269-74. 
19) Bang KS, Park JS, Kim JY, Park JY, An HS, Yun BH. Literature review on nursing intervention for 
premature infants in Korea. J Korean SocMatern Child Health 2013;17:49-61. 
20) Park HR. Effects of nonnutritive sucking on heart rate, lingual lipase activity, and behavioral state 
of low birth weight infants.가톨릭대학교 논문집 1994;47:1027-37.. 
21) Shin HS. Effects of nonnutritive sucking on behavioral state in preterm infants. Child Health Nurs 
Res 1998;4:305-13. 
22) Park HR, Park SN. Effects of nonnutritive sucking on lingual lipase activity and body weight of 
low birth weight infants with bottle feeding. Child Health Nurs Res 2001;7:236-44. 
23) Joung KH, Yoo IY, Kim HS, Kim S, Lee JH.Effects of non-nutritive sucking on the physiological 
and behavioral states of preterm infants during tube feeding. J Korean AcadNurs 2006;36:732-41. 
24) Park JH, Park HR. Effects of nonnutritive sucking on heart rate, oxygen saturation and behavioral 
state in preterm infants. Child Health Nurs Res 2007;13:299-307 
25) Kim JE. The effects of oral stimulation program on oral feeding of premature infants. Unpublished 
master’s thesis, Seoul National University, Seoul. 
26) Poore M, Barlow SM,Wang J, EstepM, Lee J. Respiratory treatment history predicts suck 
pattern stability in preterm infants. JNeonatal Nurs 2008;14(06):185–192 
27) Poore M, Zimmerman E, Barlow SM, Wang J, Gu F. Patterned orocutaneous therapy improves 
sucking and oral feeding in preterm infants. Acta Paediatr 2008;97(07):920–927 
28) Li XL, Liu Y, Liu M, Yang CY, Yang QZ. Early premature infant oral motor intervention improved 
oral feeding and prognosis by promoting neurodevelopment. Am J Perinatol 2019. doi: 10.1055/s-
0039-1685448. [Epub ahead of print] 
29) Partridge JC, Babcock DS, Steichen JJ, Han BK. Optimal timing for diagnostic cranial ultrasound 
in low-birth-weight infants: detection of intracranial hemorrhage and ventricular dilatation. J Pediatr 
1983;102:281-7.