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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28-32
SponsorPolish Mother Memorial Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

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)
2

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 (%).

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)
3

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).

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)
4

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.

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)

Secondary outcomes

1

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).

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)
2

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).

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)

Other outcomes

Locations

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