Premature InfantsNCT07656467
The Impact of Masseter Muscle Thickness on the Feeding Process in Preterm Infants in Ultrasound Assessment
An observational study of Premature Infants, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Premature Infants
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jun 2026to Dec 2029
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: The study will include premature newborns hospitalized in the Neonatology, Intensive Care and Neonatal Pathology Clinic, Polish Mother's Memorial Hospital Research Institute, Łódź, Poland
Who may be able to join
- 28+0/7-32+0/7 weeks of gestational age;
- use of one specific type of teat;
- passive oxygen therapy is permitted;
- written informed consent obtained from parents.
Who cannot join
- newborns with defects that may significantly affect the development of feeding function such as: cleft lip and/or palate, facial paralysis, and other craniofacial defects;
- newborns with a shortened anterior lingual frenulum according to the E. Coryllos classification - meeting the criteria for frenotomy according to the Hazelbaker/Amir scale;
- detected genetic defects, metabolic diseases, or suspected cases of their presence;
- newborns requiring intubation up to 10 days of life;
- low Apgar score (less than 5 points at 5 and 10 minutes of life);
- newborns with visible neurological disorders (e.g. with symptoms of hypertonia, impaired reflex reactions in the orofacial area) and/or significant abnormalities in central nervous system (CNS) imaging studies (e.g. III-IV degree intraventricular hemorrhages, CNS defects, hydrocephalus);
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- newborns of mothers with anhydramnios;
- lack of consent to conduct at least two bottle-feeding sessions;
- a child fed with a different type of teat than the one used in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Polish Mother's Memorial Hospital - Research Institute
Lodz, Łódź Voivodeship, 93-338
About this study
Official title: The Impact of Masseter Muscle Thickness on the Feeding Process in Preterm Infants in Ultrasound Assessment - an Observational Study
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.
Read the detailed description
The study will include premature infants who meet the inclusion and exclusion criteria. The first ultrasound examination (USG) of the masseter muscle thickness will be performed between 7 and 10 days of life. The second examination will be performed at the initial stage of oral feeding - when the child is consuming orally 25 to 50% of its daily nutritional requirements. If the daily requirement is expressed as a volume range (e.g., 40-45ml/serving, i.e., 320ml-360ml/day), the lower expected value will be used to calculate the child's food intake. The third examination will be performed when the child has achieved full oral feeding. The ultrasound examination will include measurement of the masseter muscle in its thickest section, from the external to the internal fascia (including their thickness), in longitudinal and transverse sections, using a linear transducer designed for musculoskeletal examinations. The transducer will be placed perpendicular to the mandibular ramus. Muscle thickness is defined as the maximum distance between the external and internal fascia. The newborn will be positioned in a supinated position during the examination. During the ultrasound examination, routine procedures will be used to support the newborn's self-regulation (e.g., swaddling, ensuring the ability to clasp hands or hold them near the face, ensuring a quiet environment, avoiding excessive and sudden sounds, etc.). A water-based transmission gel, heated in an ultrasound gel warmer to 36 degrees Celsius (98 degrees Fahrenheit), will be used during the examination to ensure the newborn's comfort and consistent examination conditions. During the examination, the ultrasound transducer will be placed on the left and then the right side of the baby's face to assess the left and right masseter muscles. The examination will be performed by a single person - a neonatologist and pediatrician specialist with extensive experience in performing ultrasound imaging in premature newborns. Performing the examination by a single person will ensure consistent pressure from the ultrasound transducer on the baby's tissues. The examination will be recorded on an ultrasound machine - recording time: 10 seconds for each area examined, i.e., a total of 20 seconds of recording (left and right masseter muscles). Data will be transferred from the ultrasound machine using a portable storage device (flash drive). The recorded examinations will then be evaluated by a radiology and imaging specialist. Masseter thickness will be measured when the muscle relaxes, defined as the absence of sucking movements in the child.
Within a maximum of 3 days from the day on which the second and third ultrasound examinations are performed, study will also be carried out to assess the course of the feeding session to evaluate the quantitative and qualitative aspects of oral feeding. Newborns will be fed in the side-lying position, positioned on their left side. The examination will include assessment of the baby before, during, and after feeding:
- 2 minutes before feeding, oxygen saturation (SpO2) and heart rate (HR) + the level of activity according to the Neonatal Behavioral Assessment Scale (NBAS);
- 3 minutes into feeding, SpO2 and HR + the level of activity according to the NBAS;
- at the end of feeding, SpO2 and HR + the level of activity according to the NBAS + volume of food consumed;
- 10 minutes after feeding, SpO2 and HR + the level of activity according to the NBAS.
SpO2 and HR will be measured using a pulse oximeter (Masimo Rad97). The pulse oximeter sensor will be placed on the right lower limb. Feeding time: measured from the moment the teat is placed in the baby's mouth until the end of feeding. The total feeding time does not include breaks in feeding, such as burping or any interruption caused by a choking episode due to sucking, breathing, and swallowing discoordination. Maximum feeding session time: 30 minutes - measured from the moment the baby is taken from the bed until the end of the feeding (removal of the teat from the baby's mouth). Breaks in feeding, such as burping, are included in the total feeding session time. After feeding, the baby may be placed in the bed or placed on the mother's or father's chest for kangaroo care. Both the feeding time and the total feeding session time will be recorded. The occurrence of choking episodes and the total duration of SpO2 drops will also be taken into account in the study. If the use of extraoral aids to improve feeding efficiency is necessary, this will be noted in the study protocol. These aids improve the seal of the lips around the teat in active newborns during feeding. They are used only when necessary, i.e., if a still-active baby develops lip slack during feeding, resulting in decreased feeding effectiveness. The volume of food consumed will be expressed as a percentage of the expected volume of food consumed per serving. The study will be video recorded. Description of feeding position: The newborn is placed in a lateral position on the examiner's lap, on the left side, at a 30-45° angle (with a folded blanket/pillow or footrest between the knees and the newborn). The baby's head is symmetrically positioned between the shoulders, supported by the hand of the person feeding the baby. The shoulder girdle is higher than the pelvic girdle, and the head and back are in a straight line - slight, natural body flexion is permitted. The legs are bent at the hips at an angle of up to 90°. The knees and ankles are in natural flexion. For the purposes of the study, data will be collected regarding the baby's maturity on the day of delivery, the type of delivery, sex, and the baby's weight at delivery. Furthermore, on the days when the ultrasound examination will be performed, the newborn's anthropometric data will be collected: body weight and head circumference. To avoid exposing newborns to additional procedures related to obtaining the above data, the baby's body weight will be recorded from the routine daily measurement, and head circumference from the last routine weekly measurement. Variables related to the process of introducing full oral feeding will also be analyzed: the day of life in which the baby reaches 50% oral feeding; the number of days from the first feeding attempt to the introduction of full oral feeding; and the average daily weight gain calculated from the first feeding attempt to the introduction of full oral feeding, as well as between the first and second, and second and third, masseter ultrasound examinations. Examination procedure: Examination I: Bilateral ultrasound assessment of the masseter muscle on the 7th-10th day of life; body weight + head circumference; Examination II: Bilateral ultrasound assessment of the masseter muscle when the infant is orally consuming 25-50% of its daily requirement; body weight + head circumference; Feeding session assessment (SpO2; drops in SpO2 below 85%, HR; feeding duration; feeding session duration; need for extraoral support; occurrence of choking episodes, activity status according to the NBAS scale; amount of food consumed); Examination III: bilateral ultrasound assessment of the masseter muscle when the child is orally consuming 100% of its daily requirement; body weight + head circumference; feeding session assessment (SpO2; drops in SpO2 below 85%, HR; feeding duration; feeding session duration; need for extraoral support; occurrence of choking episodes, activity status according to the NBAS scale; amount of food consumed).
- Conditions
- Premature Infants
- Keywords
- premature infant, masseter muscle, ultrasonography, oral feeding
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of masseter muscle thickness in premature infants
The ultrasound examination will include measurement of the right and left masseter muscle in its thickest section, from the external to the internal fascia (including their thickness), in longitudinal and transverse sections, using a linear transducer designed for musculoskeletal examinations. The transducer will be placed perpendicular to the mandibular ramus. Muscle thickness is defined as the maximum distance between the external and internal fascia. The newborn will be positioned in a supinated position during the examination.
Measured: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP).
The measurement of SpO2 will be done before, during, and after feeding:
- 2 minutes before feeding
- 3 minutes into feeding
- at the end of feeding
- 10 minutes after feeding SpO2 measurement will be performed using a pulse oximeter. The level of SpO2 will be given in percentage of oxygen saturation of hemoglobin (%).
Measured: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP).
The measurement of HR will be done before, during, and after feeding:
- 2 minutes before feeding
- 3 minutes into feeding
- at the end of feeding
- 10 minutes after feeding HR measurement will be performed using a pulse oximeter. The heart rate will be given in beats per minute (bpm).
Measured: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP).
The examination will include assessment of the baby before, during, and after feeding:
- 2 minutes before feeding
- 3 minutes into feeding
- at the end of feeding
- 10 minutes after feeding The level of activity will be determined using the six-item NBAS scale, with successive points representing the following: 1-quiet sleep, 2-active sleep, 3-drowsy, 4-quiet alert, 5-active alert, and 6-crying.
Measured: 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
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP).
Choking episodes are defined as sucking-breathing-swallowing discoordination, characterized by coughing, interruption of feeding, and the possible presence of other feeding-related symptoms that may co-occur, such as desaturation, bradycardia, respiratory effort, and decreased activity of the newborn.
If infant experiences a choking episode during a feeding session, this will be recorded in the examination report.
Measured: 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 (%)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP).
If infant experiences a decline of SpO2 to ≤85% during a feeding session, this will be recorded in the examination report. The total time of SpO2 declines will be given in seconds (secs).
Measured: 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
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP).
Total amount of food consumed by infant during feeding session will be determined at the end of feeding session and recorded in the examination report. The proportion of milk consumed is defined as volume of milk taken relative to the expected volume. The volume will be given in percentage (%).
Measured: 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
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP).
The duration of feeding will be calculated as the total time the teat will be inserted intraorally during the session. The duration of feeding session will be given in minutes and seconds (min:secs).
Measured: 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
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP).
The duration of the feeding session is defined as the total time of the study feeding intervention-that is, from the moment the infant will be taken from the bed until they will be returned to rest (in bed or on the parent's chest)-including all pauses during feeding, such as breaks for burping or breathing equalization, if will be needed.
The duration of feeding session will be given in minutes and seconds (min:secs).
Measured: 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)
Secondary outcomes (2)
The influence of head circumference on the thickness of the masseter muscle
On the days when the ultrasound examination will be performed, the newborn's head circumference will be collected. To maintain the highest ethical standards, the study will use anthropometric data routinely collected at the Clinic of Neonatology, Intensive Care and Neonatal Pathology at the Polish Mother's Hospital Research Institute. Head circumference is measured once a week. Therefore, to avoid exposing newborns to additional procedures related to collecting this data, the baby's head circumference will be collected from the last routine weekly measurement. The head circumference will be given in centimeters (cm).
Measured: 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)
The influence of body weight on the thickness of the masseter muscle
On the days when the ultrasound examination will be performed, the newborn's body weight data will be collected. To maintain the highest ethical standards, the study will use anthropometric data routinely collected at the Clinic of Neonatology, Intensive Care and Neonatal Pathology at the Polish Mother's Hospital Research Institute. Newborns are weighed daily. Therefore, to avoid exposing newborns to additional procedures related to collecting this data, the baby's body weight will be recorded from the routine daily measurement. The body weight will be given in grams (g).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start30 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Raczyńska, Polish Mother Memorial Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656467
- Sponsor's protocol ID
- PMMHRI-2026.1/1/19-GW
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Masseter Muscle Thickness on the Feeding Process in Preterm Infants in Ultrasound Assessment - an Observational Study
- ClinicalTrials.gov ID
- NCT07656467
- Acronym / sponsor ID
- PMMHRI-2026.1/1/19-GW
- Conditions
- Premature Infants
- Keywords
- premature infant, masseter muscle, ultrasonography, oral feeding
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will include premature infants who meet the inclusion and exclusion criteria. The first ultrasound examination (USG) of the masseter muscle thickness will be performed between 7 and 10 days of life. The second examination will be performed at the initial stage of oral feeding - when the child is consuming orally 25 to 50% of its daily nutritional requirements. If the daily requirement is expressed as a volume range (e.g., 40-45ml/serving, i.e., 320ml-360ml/day), the lower expected value will be used to calculate the child's food intake. The third examination will be performed when the child has achieved full oral feeding. The ultrasound examination will include measurement of the masseter muscle in its thickest section, from the external to the internal fascia (including their thickness), in longitudinal and transverse sections, using a linear transducer designed for musculoskeletal examinations. The transducer will be placed perpendicular to the mandibular ramus. Muscle thickness is defined as the maximum distance between the external and internal fascia. The newborn will be positioned in a supinated position during the examination. During the ultrasound examination, routine procedures will be used to support the newborn's self-regulation (e.g., swaddling, ensuring the ability to clasp hands or hold them near the face, ensuring a quiet environment, avoiding excessive and sudden sounds, etc.). A water-based transmission gel, heated in an ultrasound gel warmer to 36 degrees Celsius (98 degrees Fahrenheit), will be used during the examination to ensure the newborn's comfort and consistent examination conditions. During the examination, the ultrasound transducer will be placed on the left and then the right side of the baby's face to assess the left and right masseter muscles. The examination will be performed by a single person - a neonatologist and pediatrician specialist with extensive experience in performing ultrasound imaging in premature newborns. Performing the examination by a single person will ensure consistent pressure from the ultrasound transducer on the baby's tissues. The examination will be recorded on an ultrasound machine - recording time: 10 seconds for each area examined, i.e., a total of 20 seconds of recording (left and right masseter muscles). Data will be transferred from the ultrasound machine using a portable storage device (flash drive). The recorded examinations will then be evaluated by a radiology and imaging specialist. Masseter thickness will be measured when the muscle relaxes, defined as the absence of sucking movements in the child.
Within a maximum of 3 days from the day on which the second and third ultrasound examinations are performed, study will also be carried out to assess the course of the feeding session to evaluate the quantitative and qualitative aspects of oral feeding. Newborns will be fed in the side-lying position, positioned on their left side. The examination will include assessment of the baby before, during, and after feeding:
- 2 minutes before feeding, oxygen saturation (SpO2) and heart rate (HR) + the level of activity according to the Neonatal Behavioral Assessment Scale (NBAS);
- 3 minutes into feeding, SpO2 and HR + the level of activity according to the NBAS;
- at the end of feeding, SpO2 and HR + the level of activity according to the NBAS + volume of food consumed;
- 10 minutes after feeding, SpO2 and HR + the level of activity according to the NBAS.
SpO2 and HR will be measured using a pulse oximeter (Masimo Rad97). The pulse oximeter sensor will be placed on the right lower limb. Feeding time: measured from the moment the teat is placed in the baby's mouth until the end of feeding. The total feeding time does not include breaks in feeding, such as burping or any interruption caused by a choking episode due to sucking, breathing, and swallowing discoordination. Maximum feeding session time: 30 minutes - measured from the moment the baby is taken from the bed until the end of the feeding (removal of the teat from the baby's mouth). Breaks in feeding, such as burping, are included in the total feeding session time. After feeding, the baby may be placed in the bed or placed on the mother's or father's chest for kangaroo care. Both the feeding time and the total feeding session time will be recorded. The occurrence of choking episodes and the total duration of SpO2 drops will also be taken into account in the study. If the use of extraoral aids to improve feeding efficiency is necessary, this will be noted in the study protocol. These aids improve the seal of the lips around the teat in active newborns during feeding. They are used only when necessary, i.e., if a still-active baby develops lip slack during feeding, resulting in decreased feeding effectiveness. The volume of food consumed will be expressed as a percentage of the expected volume of food consumed per serving. The study will be video recorded. Description of feeding position: The newborn is placed in a lateral position on the examiner's lap, on the left side, at a 30-45° angle (with a folded blanket/pillow or footrest between the knees and the newborn). The baby's head is symmetrically positioned between the shoulders, supported by the hand of the person feeding the baby. The shoulder girdle is higher than the pelvic girdle, and the head and back are in a straight line - slight, natural body flexion is permitted. The legs are bent at the hips at an angle of up to 90°. The knees and ankles are in natural flexion. For the purposes of the study, data will be collected regarding the baby's maturity on the day of delivery, the type of delivery, sex, and the baby's weight at delivery. Furthermore, on the days when the ultrasound examination will be performed, the newborn's anthropometric data will be collected: body weight and head circumference. To avoid exposing newborns to additional procedures related to obtaining the above data, the baby's body weight will be recorded from the routine daily measurement, and head circumference from the last routine weekly measurement. Variables related to the process of introducing full oral feeding will also be analyzed: the day of life in which the baby reaches 50% oral feeding; the number of days from the first feeding attempt to the introduction of full oral feeding; and the average daily weight gain calculated from the first feeding attempt to the introduction of full oral feeding, as well as between the first and second, and second and third, masseter ultrasound examinations. Examination procedure: Examination I: Bilateral ultrasound assessment of the masseter muscle on the 7th-10th day of life; body weight + head circumference; Examination II: Bilateral ultrasound assessment of the masseter muscle when the infant is orally consuming 25-50% of its daily requirement; body weight + head circumference; Feeding session assessment (SpO2; drops in SpO2 below 85%, HR; feeding duration; feeding session duration; need for extraoral support; occurrence of choking episodes, activity status according to the NBAS scale; amount of food consumed); Examination III: bilateral ultrasound assessment of the masseter muscle when the child is orally consuming 100% of its daily requirement; body weight + head circumference; feeding session assessment (SpO2; drops in SpO2 below 85%, HR; feeding duration; feeding session duration; need for extraoral support; occurrence of choking episodes, activity status according to the NBAS scale; amount of food consumed).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will include premature newborns hospitalized in the Neonatology, Intensive Care and Neonatal Pathology Clinic, Polish Mother's Memorial Hospital Research Institute, Łódź, Poland
Key inclusion criteria (4 listed)
- 28+0/7-32+0/7 weeks of gestational age;
- use of one specific type of teat;
- passive oxygen therapy is permitted;
- written informed consent obtained from parents.
Key exclusion criteria (9 listed)
- newborns with defects that may significantly affect the development of feeding function such as: cleft lip and/or palate, facial paralysis, and other craniofacial defects;
- newborns with a shortened anterior lingual frenulum according to the E. Coryllos classification - meeting the criteria for frenotomy according to the Hazelbaker/Amir scale;
- detected genetic defects, metabolic diseases, or suspected cases of their presence;
- newborns requiring intubation up to 10 days of life;
- low Apgar score (less than 5 points at 5 and 10 minutes of life);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of masseter muscle thickness in premature infants
Time frame: 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)
The ultrasound examination will include measurement of the right and left masseter muscle in its thickest section, from the external to the internal fascia (including their thickness), in longitudinal and transverse sections, using a linear transducer designed for musculoskeletal examinations. The transducer will be placed perpendicular to the mandibular ramus. Muscle thickness is defined as the maximum distance between the external and internal fascia. The newborn will be positioned in a supinated position during the examination.
Examination of the course of feeding sessions to assess the qualitative aspects of oral feeding - oxygen saturation level (SpO2)
Time frame: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP). The measurement of SpO2 will be done before, during, and after feeding: * 2 minutes before feeding * 3 minutes into feeding * at the end of feeding * 10 minutes after feeding SpO2 measurement will be performed using a pulse oximeter. The level of SpO2 will be given in percentage of oxygen saturation of hemoglobin (%).
Examination of the course of feeding sessions to assess the qualitative aspects of oral feeding - heart rate (HR)
Time frame: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP). The measurement of HR will be done before, during, and after feeding: * 2 minutes before feeding * 3 minutes into feeding * at the end of feeding * 10 minutes after feeding HR measurement will be performed using a pulse oximeter. The heart rate will be given in beats per minute (bpm).
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)
Time frame: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP). The examination will include assessment of the baby before, during, and after feeding: * 2 minutes before feeding * 3 minutes into feeding * at the end of feeding * 10 minutes after feeding The level of activity will be determined using the six-item NBAS scale, with successive points representing the following: 1-quiet sleep, 2-active sleep, 3-drowsy, 4-quiet alert, 5-active alert, and 6-crying.
Examination of the course of feeding sessions to assess the qualitative aspects of oral feeding - the occurrence of choking episodes
Time frame: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP). Choking episodes are defined as sucking-breathing-swallowing discoordination, characterized by coughing, interruption of feeding, and the possible presence of other feeding-related symptoms that may co-occur, such as desaturation, bradycardia, respiratory effort, and decreased activity of the newborn. If infant experiences a choking episode during a feeding session, this will be recorded in the examination report.
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 (%)
Time frame: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP). If infant experiences a decline of SpO2 to ≤85% during a feeding session, this will be recorded in the examination report. The total time of SpO2 declines will be given in seconds (secs).
Examination of the course of feeding sessions to assess the quantitative aspects of oral feeding - proportion of food eaten during feeding session
Time frame: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP). Total amount of food consumed by infant during feeding session will be determined at the end of feeding session and recorded in the examination report. The proportion of milk consumed is defined as volume of milk taken relative to the expected volume. The volume will be given in percentage (%).
Examination of the course of feeding sessions to assess the quantitative aspects of oral feeding - feeding duration
Time frame: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP). The duration of feeding will be calculated as the total time the teat will be inserted intraorally during the session. The duration of feeding session will be given in minutes and seconds (min:secs).
Examination of the course of feeding sessions to assess the quantitative aspects of oral feeding - feeding session duration
Time frame: 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)
Newborns will be fed in the side-lying position, positioned on their left side, using a single type of teat for premature newborns, made of thermoplastic elastomer. The feeding session will be conducted by a Speech-Language Pathologist (SLP). The duration of the feeding session is defined as the total time of the study feeding intervention-that is, from the moment the infant will be taken from the bed until they will be returned to rest (in bed or on the parent's chest)-including all pauses during feeding, such as breaks for burping or breathing equalization, if will be needed. The duration of feeding session will be given in minutes and seconds (min:secs).
2 secondary outcomes
The influence of head circumference on the thickness of the masseter muscle
Time frame: 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)
The influence of body weight on the thickness of the masseter muscle
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infants, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of masseter muscle thickness in premature infants (time frame: 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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.