The aim of this study is to assess masseter muscle thickness using ultrasounds during oral feeding process in premature infants with gestational age from 28+0/7 to 32+0/7 weeks, taking into account the qualitative and quantitative aspects of oral feeding. The main question it aims to answer is: Does the thickness of the masseter muscle influence the course of development of the feeding function in premature newborns? The study will assess the influence of masseter muscle thickness on the oral feeding process in premature infants, which has significant cognitive value due to the dynamic development of feeding function in this group of newborns. Transitioning from enteral feeding via a nasogastric tube to full oral feeding is a crucial stage in the development of one of the most fundamental life functions - nutrition. Complete, effective, and safe oral feeding is also a factor in determining a newborn's discharge from the hospital. Research in the area of feeding is an important and ongoing goal for improving neonatal care in neonatal units. Furthermore, this study will provide preliminary data on masseter muscle thickness in premature infants, which may serve as a basis for further research.
Age range
28 Weeks – 32 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Measurement of masseter muscle thickness in premature infants
Timeframe: Baseline measurement: 7-10 day of life; second measurement: average 34-35 weeks of gestational age (when infant consumed 25-50% food orally); third measurement: average 36-40 weeks of gestational age (when infant intake 100% of food orally)
Examination of the course of feeding sessions to assess the qualitative aspects of oral feeding - oxygen saturation level (SpO2)
Timeframe: First examination: within a maximum of 3 days from second ultrasound examination (when baby intake 25-50% of food orally). Second examination: within a maximum of 3 days from a third ultrasound examination (when baby intake 100% of food orally)
Examination of the course of feeding sessions to assess the qualitative aspects of oral feeding - heart rate (HR)
Timeframe: First examination: within a maximum of 3 days from second ultrasound examination (when baby intake 25-50% of food orally). Second examination: within a maximum of 3 days from a third ultrasound examination (when baby intake 100% of food orally)
Examination of the course of feeding sessions to assess the qualitative aspects of oral feeding - the level of activity according to the Neonatal Behavioral Assessment Scale (NBAS)
Timeframe: First examination: within a maximum of 3 days from second ultrasound examination (when baby intake 25-50% of food orally). Second examination: within a maximum of 3 days from a third ultrasound examination (when baby intake 100% of food orally)
Examination of the course of feeding sessions to assess the qualitative aspects of oral feeding - the occurrence of choking episodes
Timeframe: First examination: within a maximum of 3 days from second ultrasound examination (when baby intake 25-50% of food orally). Second examination: within a maximum of 3 days from a third ultrasound examination (when baby intake 100% of food orally)
Examination of the course of feeding sessions to assess the qualitative aspects of oral feeding - the total time of oxygen saturation (SpO2) declines to ≤85 percent (%)
Timeframe: First examination: within a maximum of 3 days from second ultrasound examination (when baby intake 25-50% of food orally). Second examination: within a maximum of 3 days from a third ultrasound examination (when baby intake 100% of food orally)
Examination of the course of feeding sessions to assess the quantitative aspects of oral feeding - proportion of food eaten during feeding session
Timeframe: First examination: within a maximum of 3 days from second ultrasound examination (when baby intake 25-50% of food orally). Second examination: within a maximum of 3 days from a third ultrasound examination (when baby intake 100% of food orally)
Examination of the course of feeding sessions to assess the quantitative aspects of oral feeding - feeding duration
Timeframe: First examination: within a maximum of 3 days from second ultrasound examination (when baby intake 25-50% of food orally). Second examination: within a maximum of 3 days from a third ultrasound examination (when baby intake 100% of food orally)
Examination of the course of feeding sessions to assess the quantitative aspects of oral feeding - feeding session duration
Timeframe: First examination: within a maximum of 3 days from second ultrasound examination (when baby intake 25-50% of food orally). Second examination: within a maximum of 3 days from a third ultrasound examination (when baby intake 100% of food orally)