PrematurityNeoMassageNCT06273202
Ultrasound Monitoring of Muscle Thickness in Premature Patients
A study testing Infant Massage in people with Prematurity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 28 to 35 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- Infant Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2024to Dec 2025
- Phase
- Interventional
- 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 35 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Prematurity
- Being tested
- Infant Massage
- Keywords
- prematurity, Infant Massage, Thigh ultrasound, muscle ultrasound
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant MassageOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | 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). Receives: Other: Infant Massage |
| Control group (standard care) | No intervention | Infants in this group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps femuri thickness
Thigh ultrasound will be performed to measure quadriceps femuri thickness
Measured: Change of quadriceps femur thickness from baseline at 1, 2,3,4,5 weeks
Quadriceps femuri trophism
The Heckmatt scale will be used to assess muscle trophism (grades I to IV, where I is normal and IV abnormal)
Measured: Change of quadriceps femur tropism from baseline at 1, 2,3,4,5 weeks
Secondary outcomes (3)
To valuate the discomfort/behavioral status of the infant.
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.
Measured: 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.
Assessment by Prechtl General Movement Optimality Score, from 5 (worse) to 42 (normal)
Measured: Change of General Movement Optimality Score of the infant from baseline at 1, 2,3,4,5 weeks
To evaluate differences in ponderal growth.
Body weight measurement (grams).
Measured: Change of General Movement Optimality Score of the infant from baseline at 1, 2,3,4,5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start7 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobile Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Stefano Nobile, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273202
- Sponsor's protocol ID
- 6257
- Acronym
- NeoMassage
- Status last verified
- Aug 2025
- First submitted
- 9 Feb 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertini G, Elia S, Dani C. Using ultrasound to examine muscle mass in preterm infants at term-equivalent age. Eur J Pediatr. 2021 Feb;180(2):461-468. doi: 10.1007/s00431-020-03846-7. Epub 2020 Oct 20.
PubMed 33083899Su E, Dalesio N, Pustavoitau A. Point-of-care ultrasound in pediatric anesthesiology and critical care medicine. Can J Anaesth. 2018 Apr;65(4):485-498. doi: 10.1007/s12630-018-1066-6. Epub 2018 Jan 19.
PubMed 29352416Sitka U. [The startle reaction of the newborn infant]. Zentralbl Gynakol. 1990;112(14):911-9. German.
PubMed 2264411Neu M, Robinson J. Maternal holding of preterm infants during the early weeks after birth and dyad interaction at six months. J Obstet Gynecol Neonatal Nurs. 2010 Jul-Aug;39(4):401-14. doi: 10.1111/j.1552-6909.2010.01152.x.
PubMed 20629927Harrison L, Olivet L, Cunningham K, Bodin MB, Hicks C. Effects of gentle human touch on preterm infants: pilot study results. Neonatal Netw. 1996 Mar;15(2):35-42.
PubMed 8700092Lai MM, D'Acunto G, Guzzetta A, Boyd RN, Rose SE, Fripp J, Finnigan S, Ngenda N, Love P, Whittingham K, Pannek K, Ware RS, Colditz PB. PREMM: preterm early massage by the mother: protocol of a randomised controlled trial of massage therapy in very preterm infants. BMC Pediatr. 2016 Aug 27;16(1):146. doi: 10.1186/s12887-016-0678-7.
PubMed 27568006Beachy JM. Premature infant massage in the NICU. Neonatal Netw. 2003 May-Jun;22(3):39-45. doi: 10.1891/0730-0832.22.3.39.
PubMed 12795507Mrljak R, Arnsteg Danielsson A, Hedov G, Garmy P. Effects of Infant Massage: A Systematic Review. Int J Environ Res Public Health. 2022 May 24;19(11):6378. doi: 10.3390/ijerph19116378.
PubMed 35681968Field T, Diego M, Hernandez-Reif M. Preterm infant massage therapy research: a review. Infant Behav Dev. 2010 Apr;33(2):115-24. doi: 10.1016/j.infbeh.2009.12.004.
PubMed 20137814Pados BF, McGlothen-Bell K. Benefits of Infant Massage for Infants and Parents in the NICU. Nurs Womens Health. 2019 Jun;23(3):265-271. doi: 10.1016/j.nwh.2019.03.004. Epub 2019 May 3.
PubMed 31059673Pozzi N, D'Angelo G, Gitto E; Gruppo di Studio Terapia Intensiva della Prima Infanzia della SIN. Why is "early childhood intensive care" an Italian association of neonatology study group? Ital J Pediatr. 2019 Mar 6;45(1):33. doi: 10.1186/s13052-019-0626-x.
PubMed 30841913van Alfen N, Gijsbertse K, de Korte CL. How useful is muscle ultrasound in the diagnostic workup of neuromuscular diseases? Curr Opin Neurol. 2018 Oct;31(5):568-574. doi: 10.1097/WCO.0000000000000589.
PubMed 30028736Perri A, Sbordone A, Patti ML, Nobile S, Tirone C, Giordano L, Tana M, D'Andrea V, Priolo F, Serrao F, Riccardi R, Prontera G, Maddaloni C, Lenkowicz J, Boldrini L, Vento G. Early lung ultrasound score to predict noninvasive ventilation needing in neonates from 33 weeks of gestational age: A multicentric study. Pediatr Pulmonol. 2022 Sep;57(9):2227-2236. doi: 10.1002/ppul.26031. Epub 2022 Jun 20.
PubMed 35670034Dubowitz LM, Dubowitz V, Palmer P, Verghote M. A new approach to the neurological assessment of the preterm and full-term newborn infant. Brain Dev. 1980;2(1):3-14. doi: 10.1016/s0387-7604(80)80003-9.
PubMed 7416439Einspieler C, Prechtl HF. Prechtl's assessment of general movements: a diagnostic tool for the functional assessment of the young nervous system. Ment Retard Dev Disabil Res Rev. 2005;11(1):61-7. doi: 10.1002/mrdd.20051.
PubMed 15856440
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Monitoring of Muscle Thickness in Premature Patients Undergoing Infant Massage: Experience in a Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06273202
- Acronym / sponsor ID
- NeoMassage / 6257
- Conditions
- Prematurity
- Keywords
- prematurity, Infant Massage, Thigh ultrasound, muscle ultrasound
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Feb 2024 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: Infant MassageInfants 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). |
| Control group (standard care) | No intervention | –Infants in this group will receive standard care. |
Who may qualify
- Ages
- 28 to 35 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant MassageInfant 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 | Massage |
Primary outcome
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
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)
3 secondary outcomes
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
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
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
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 28 Aug 2025.
- Results publication: PubMed 33083899Bertini G, Elia S, Dani C. Using ultrasound to examine muscle mass in preterm infants at term-equivalent age. Eur J Pediatr. 2021 Feb;180(2):461-468. doi: 10.1007/s00431-020-03846-7. Epub 2020 Oct 20.
- Results publication: PubMed 29352416Su E, Dalesio N, Pustavoitau A. Point-of-care ultrasound in pediatric anesthesiology and critical care medicine. Can J Anaesth. 2018 Apr;65(4):485-498. doi: 10.1007/s12630-018-1066-6. Epub 2018 Jan 19.
- Results publication: PubMed 2264411Sitka U. [The startle reaction of the newborn infant]. Zentralbl Gynakol. 1990;112(14):911-9. German.
- Results publication: PubMed 20629927Neu M, Robinson J. Maternal holding of preterm infants during the early weeks after birth and dyad interaction at six months. J Obstet Gynecol Neonatal Nurs. 2010 Jul-Aug;39(4):401-14. doi: 10.1111/j.1552-6909.2010.01152.x.
- Results publication: PubMed 8700092Harrison L, Olivet L, Cunningham K, Bodin MB, Hicks C. Effects of gentle human touch on preterm infants: pilot study results. Neonatal Netw. 1996 Mar;15(2):35-42.
- Results publication: PubMed 27568006Lai MM, D'Acunto G, Guzzetta A, Boyd RN, Rose SE, Fripp J, Finnigan S, Ngenda N, Love P, Whittingham K, Pannek K, Ware RS, Colditz PB. PREMM: preterm early massage by the mother: protocol of a randomised controlled trial of massage therapy in very preterm infants. BMC Pediatr. 2016 Aug 27;16(1):146. doi: 10.1186/s12887-016-0678-7.
- Results publication: PubMed 12795507Beachy JM. Premature infant massage in the NICU. Neonatal Netw. 2003 May-Jun;22(3):39-45. doi: 10.1891/0730-0832.22.3.39.
- Results publication: PubMed 35681968Mrljak R, Arnsteg Danielsson A, Hedov G, Garmy P. Effects of Infant Massage: A Systematic Review. Int J Environ Res Public Health. 2022 May 24;19(11):6378. doi: 10.3390/ijerph19116378.
- Results publication: PubMed 20137814Field T, Diego M, Hernandez-Reif M. Preterm infant massage therapy research: a review. Infant Behav Dev. 2010 Apr;33(2):115-24. doi: 10.1016/j.infbeh.2009.12.004.
- Results publication: PubMed 31059673Pados BF, McGlothen-Bell K. Benefits of Infant Massage for Infants and Parents in the NICU. Nurs Womens Health. 2019 Jun;23(3):265-271. doi: 10.1016/j.nwh.2019.03.004. Epub 2019 May 3.
- Results publication: PubMed 30841913Pozzi N, D'Angelo G, Gitto E; Gruppo di Studio Terapia Intensiva della Prima Infanzia della SIN. Why is "early childhood intensive care" an Italian association of neonatology study group? Ital J Pediatr. 2019 Mar 6;45(1):33. doi: 10.1186/s13052-019-0626-x.
- Results publication: PubMed 30028736van Alfen N, Gijsbertse K, de Korte CL. How useful is muscle ultrasound in the diagnostic workup of neuromuscular diseases? Curr Opin Neurol. 2018 Oct;31(5):568-574. doi: 10.1097/WCO.0000000000000589.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stefano Nobile, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Massage in people with Prematurity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. 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 Italy. 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?
Quadriceps femuri thickness (time frame: Change of quadriceps femur thickness from baseline at 1, 2,3,4,5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273202, which also lists 20 linked publications.
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 28 Aug 2025.