Ultrasound Monitoring of Muscle Thickness in Premature Patients (NeoMassage)

February 20, 2024 updated by: Nobile Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Ultrasound Monitoring of Muscle Thickness in Premature Patients Undergoing Infant Massage: Experience in a Neonatal Intensive Care Unit

The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.

The main questions it aims to answer are:

  • To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris.
  • Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant.

Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control.

Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).

Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • gestational age between 28and 35 weeks;
  • day of life ≥ 7 (to ensure passing the transition phase);
  • clinically stable infants, either in spontaneous breathing or ventilatory support invasive or noninvasive, with a good ability to regulate states and good stress management.

Exclusion Criteria:

  • Brain pathologies;
  • Dysmorphisms;
  • Clinically unstable patients requiring treatment with inotropes and/or nitric oxide nitric acid and/or drug therapy for closure of the ductus arteriosus of Botallo.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Massage
Infants will be randomized to receive infant massage or not. Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).
Other: Infant Massage
Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).
No Intervention: Control group (standard care)
Infants in this group will receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps femuri thickness
Time Frame: Change of quadriceps femur thickness from baseline at 1, 2,3,4,5 weeks
Thigh ultrasound will be performed to measure quadriceps femuri thickness
Change of quadriceps femur thickness from baseline at 1, 2,3,4,5 weeks
Quadriceps femuri trophism
Time Frame: Change of quadriceps femur tropism from baseline at 1, 2,3,4,5 weeks
The Heckmatt scale will be used to assess muscle trophism (grades I to IV, where I is normal and IV abnormal)
Change of quadriceps femur tropism from baseline at 1, 2,3,4,5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To valuate the discomfort/behavioral status of the infant.
Time Frame: Change of discomfort ,behavioral status of the infant from baseline at 1, 2,3,4,5 weeks
Assessment by N-PASS: Neonatal Pain, Agitation and Sedation Scale (0-no pain to 10-pain) Anamnestic collection of information on the child's behavioral status: crying, consolability, adjustment to states, stress response (tidal; tremors; startle); activity level.
Change of discomfort ,behavioral status of the infant from baseline at 1, 2,3,4,5 weeks
To valuate the potential effects on spontaneous motility.
Time Frame: Change of General Movement Optimality Score of the infant from baseline at 1, 2,3,4,5 weeks
Assessment by Prechtl General Movement Optimality Score, from 5 (worse) to 42 (normal)
Change of General Movement Optimality Score of the infant from baseline at 1, 2,3,4,5 weeks
To evaluate differences in ponderal growth.
Time Frame: Change of General Movement Optimality Score of the infant from baseline at 1, 2,3,4,5 weeks
Body weight measurement (grams).
Change of General Movement Optimality Score of the infant from baseline at 1, 2,3,4,5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Stefano Nobile, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prematurity

Clinical Trials on Infant Massage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe