Effect of Non-nutritive Sucking on Feeding Intolerance in Premature Infants
Phase: NA
Conditions: Non-nutritive Sucking
Sponsor: Chang Gung Memorial Hospital

Version date：2022/05/20_Version 1.0 
 
English Synopsis 
I. Title of Study 
Effect of non-nutritive sucking on feeding intolerance in premature Infants 
II. Indication 
To study the effect of non-nutritive sucking on feeding intolerance in premature 
infants.  
III. Phase of Development: 
This is a study for a master thesis. Not applicable. 
IV. Study Rationale:  
Premature babies are defined as babies born alive before 37 weeks of pregnancy. 
There was 10.5% preterm of whole pregnancy in Taiwan, including 9.14% low 
birth weight (LBW) who born weighting between 1500-2499 g and 1.02% very 
low birth weight (VLBW) who born weighing under 1500 g. Generally, more 
early gestational ages and lower birth weight accompany more problems. They 
need to accept professional supervision, monitoring, and caring to maintain their 
growth in the neonatal intensive care unit (NICU). Premature infants need a 
progressive nasogastric tube diet to meet their nutritional needs due to the 
immature gastrointestinal tract. However, feeding intolerance, such as gastric 
residual volume (GRV), meteorism, and milk regurgitation, is also increased due 
to an immature, less functional gastrointestinal tract. This symptom will result in 
less feeding or fasting, which makes premature infants cannot get enough enteral 
nutrition and extrauterine growth restriction (EUGR). Although there is no 
standard guideline for relieving feeding intolerance symptoms and providing 
enough nutrients until now, non-nutritive sucking (NNS) was thought to have the 
benefit premature infants. It can stabilize an infant’s emotions, and physiological 
condition, relieve pain, promote the development of sucking, increase the 
efficacy of oral feeding, decrease the time of nasogastric tube feeding and 
shorten the hospital stay. This study wants to evaluate whether the different 
times of NNS before feeding can decrease the incidence of feeding intolerance.  
V. Study Objectives: 
To evaluate whether non-nutritive sucking before oral feeding can reduce the 
feeding intolerance, such as gastric residual volume (GRV), meteorism, and 

Version date：2022/05/20_Version 1.0 
 
milk regurgitation.  
VI. Study Design 
 Duration of Treatment 
3 days 
 
 Number of Planned Patients 
180 participants, 146 evaluable participants. 
 Birth between Week (26-27)+6 days:  
Experiment A group:30, Experiment B group:30, Control 
group: 30 
 Birth between Week (28-31)+6 days, above : 
Experiment A group:30, Experiment B group:30, Control 
group: 30 
 
 Investigational Product 
Not applicable. 
 
 Endpoints 
Primary endpoint: 
To evaluate whether non-nutritive sucking before oral feeding 
can reduce the feeding intolerance, such as gastric residual 
volume (GRV), meteorism, and milk regurgitation, compared to 
no intervention. 
 
Secondary endpoint: 
To evaluate whether 5 minutes of non-nutritive sucking before 
oral feeding can reduce the feeding intolerance, such as gastric 
residual volume (GRV), meteorism, and milk regurgitation, 
better than 15 minutes of non-nutritive sucking before oral 
feeding. 
 
 Criteria for Evaluation 
The full analysis set (FAS) means all the data of a participant 
was collected and an intent-to-treat set (ITT) means data of a 
participant with at least 4 interventions was collected. The 
primary and secondary endpoints will be analyzed by a FAS and 
an ITT. 

Version date：2022/05/20_Version 1.0 
 
 
 Statistical Methods 
For the primary and secondary endpoint, all the data will be 
checked their normal distribution by Kolmogorov-Smirnov 
analysis to determine whether to use parametric or nonparametric 
statistics. The difference in gastric residual volume (GRV), 
meteorism, and milk regurgitation between the NNS intervention 
and no intervention will be analyzed by the generalized 
estimating equations of SPSS 21,  value will be set at 0.05.  
 
 Duration of the Study 
2022/07/01 to 2024/06/30, a total of 2 years. 
 
 End of Study 
The sponsor reserves the right to terminate the study, according 
to the master thesis progression. The sponsor may terminate the 
study due to the following situations: 
i. 
The master thesis topic is changed. 
ii. 
The data show a significant result to the hypothesis, 
although the recruited number does not reach 180. 
The investigator should notify the IRB in writing of the study’s 
completion or early termination and send a copy of the 
notification to the sponsor.