The Impact of Masseter Muscle Thickness on the Feeding Process in Preterm Infants in Ultrasound Assessment

NCT07656467 | Enrolling By Invitation

• 1 other identifier: PMMHRI-2026.1/1/19-GW
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Premature Infants

Keywords

premature infant; masseter muscle; ultrasonography; oral feeding

Outcome Measures

Primary Outcomes (9)

• 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.

  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 (%).

  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).

  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.

  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.

  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).

  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 (%).

  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).

  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).

  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

  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

  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)

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• +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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

Polish Mother's Memorial Hospital - Research Institute

Lodz, Łódź Voivodeship, 93-338, Poland

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 18, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

PL (1)