Use of Dynamic Elastometric Body in Preterm Newborns (BODYNEO)
March 4, 2024 updated by: Romeo Domenico Marco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Use of Dynamic Elastometric Body in Preterm Newborns: A Prospective Pilot Study With a Medical Device
The goal of this prospective pilot study is to test the use of dynamic elastomeric body in a population of preterm newborns with hyperexcitability syndrome.
The main questions it aims to answer are:
- To evaluate the effectiveness of the body in elasto-compressive material (FLEXA) in addition to standard care;
- To evaluate how the use of dynamic elastomeric body promote postural containment, reduce hyperexcitability (tremor and crying), improve the organization of movement and reduce respiratory distress.
Participants will be given to routine clinical evaluations that are part of the standard of care of the premature infant admitted to Neonatology.
The clinical evaluation shall consist of:
- Hammersmith neonatal neurological examination;
- Neonatal Intensive Care Unit Network Neurobehavioural Scale (NNNS);
- General Movement's (GM's)
- Goal Attainment Scaling (GAS) Researchers will compare a study group that will be subjected to treatment with the body in elasto-compressive material and a control group without using the body in elasto-compressive material.
Study Overview
Status
Enrolling by invitation
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 Locations
-
-
-
Rome, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
-
-
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
No
Description
Inclusion Criteria:
- Signs of hyperexcitability such as tremors, sudden and chaotic movements, prevalent extensor tone, postural instability and/or neurovegetative phenomena;
- Low neurological risk, i.e., according to the protocols implemented in the standard clinical practice of the Neonatology unit, a cerebral ultrasound is performed for those born between 28-32 weeks of GA, and for those born before 28 weeks of GA, an MRI of the brain) from which it may derive;
- Cerebral ultrasound normal or with minor ultrasound findings such as grade 1 intraventricular hemorrhage (germinal matrix hemorrhage with intraventricular hemorrhage covering less than 10% of the ventricular area in the parasagittal window), or evidence of transient focal white matter hyperechogenicity.
- Issue of informed consent by the parent or legal guardian.
Exclusion Criteria:
- Neuroimaging findings of major brain lesions, such as evidence of grade 2 or greater intraventricular hemorrhage on cerebral ultrasonography (germinal matrix hemorrhage with intraventricular hemorrhage over 10% of the ventricular area in the parasagittal window/with periventricular hyperechogenicity ) or persistent hyperechogenicity for more than a week;
- Presence of: ongoing infectious states and/or sepsis, ostomy wearers, severe cardio-respiratory disorders at the time of enrolment; diagnosis of genetic or metabolic diseases; carriers of cerebral malformations; invasive or non-invasive respiratory assistance;
- Failure to issue informed consent by the parent or legal guardian.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dynamic Elastometric Body and neurological evaluation
Use of dynamic elastometric body for one week and neurological evaluation before use of body, at 30 minutes after application, at one week after using the device and at 1th months since discharge
|
The study group made up of 12 newborns will use Flexa bodysuits made to the measurements of newborns.The bodysuit will be worn for a minimum of 4 hours and a maximum of 6 hours each day for a week (depending on any signs of discomfort).
After 6 hours, the body will be removed and reapplied the next day for 4-6 hours.
The child will use the same leotard for the entire study period (1 week) and changed only if dirty.
|
|
No Intervention: Neurological evaluation
Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
Time Frame: baseline
|
Modification or reduction of hyperexcitability syndrome with use of Dynamic Elastometric Bodysuit in addition to standard care in terms of improvement of Goal Attainment Scaling (GAS) between the two groups.
The GAS scale report a 5 level score between -2 ( worse score) to +2 (better score)
|
baseline
|
|
Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
Time Frame: One week of application of Dynamic Elastometric Body
|
Modification or reduction of hyperexcitability syndrome with use of Dynamic Elastometric Bodysuit in addition to standard care in terms of improvement of Goal Attainment Scaling (GAS) between the two groups.
The GAS scale report a 5 level score between -2 ( worse score) to +2 (better score)
|
One week of application of Dynamic Elastometric Body
|
|
Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
Time Frame: at one month from hospital discharge
|
Modification or reduction of hyperexcitability syndrome with use of Dynamic Elastometric Bodysuit in addition to standard care in terms of improvement of Goal Attainment Scaling (GAS) between the two groups.
The GAS scale report a 5 level score between -2 ( worse score) to +2 (better score)
|
at one month from hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
Time Frame: baseline
|
Differences in neurological evaluation indices carried out with Hammersmith neonatal neurological examination between the two groups.
The HNNE report a score between 0 and 34; scores >30.5 are considered normal.
|
baseline
|
|
Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
Time Frame: One week after the use of Dynamic Elastometric Body
|
Differences in neurological evaluation indices carried out with Hammersmith neonatal neurological examination between the two groups.
The HNNE report a score between 0 and 34; scores >30.5 are considered normal.
|
One week after the use of Dynamic Elastometric Body
|
|
Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
Time Frame: At one month from hospital discharge
|
Differences in neurological evaluation indices carried out with Hammersmith neonatal neurological examination between the two groups.
The HNNE report a score between 0 and 34; scores >30.5 are considered normal.
|
At one month from hospital discharge
|
|
Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
Time Frame: baseline
|
Differences in neurological evaluation indices carried out with NICU Network Neurobehavioural Scale between the two group.
The NNNS considering the 10th and 90th percentiles as cutoff points for normative performance.
|
baseline
|
|
Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
Time Frame: One week after the use of Dynamic Elastometric Body
|
Differences in neurological evaluation indices carried out with NICU Network Neurobehavioural Scale between the two groups.
The NNNS considering the 10th and 90th percentiles as cutoff points for normative performance.
|
One week after the use of Dynamic Elastometric Body
|
|
Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
Time Frame: At one month from hospital discharge
|
Differences in neurological evaluation indices carried out with NICU Network Neurobehavioural Scale between the two groups.
The NNNS considering the 10th and 90th percentiles as cutoff points for normative performance.
|
At one month from hospital discharge
|
|
Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
Time Frame: baseline
|
Differences in neurological evaluation indices carried out with General movements between the two groups.
The GMs report a classification in: normal writhing, poor repertoire, cramped synchronised and chaotic.
The classification considering cramped synchronised and chaotic movements pathological.
|
baseline
|
|
Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
Time Frame: One week after the use of Dynamic Elastometric Body
|
Differences in neurological evaluation indices carried out with General movements between the two groups.
The GMs report a classification in: normal writhing, poor repertoire, cramped synchronised and chaotic.
The classification considering cramped synchronised and chaotic movements pathological.
|
One week after the use of Dynamic Elastometric Body
|
|
Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
Time Frame: At one month from hospital discharge
|
Differences in neurological evaluation indices carried out with General movements between the two groups.
The GMs report a classification in: normal writhing, poor repertoire, cramped synchronised and chaotic.
The classification considering cramped synchronised and chaotic movements pathological.
|
At one month from hospital discharge
|
|
Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
Time Frame: At 30 minutes from the use of Dynamic Elastometric Body
|
Evaluation of the variation of neurological evaluation indices carried out with General movements in the study group.
The GMs report a classification in: normal writhing, poor repertoire, cramped synchronised and chaotic.
The classification considering cramped synchronised and chaotic movements pathological.
|
At 30 minutes from the use of Dynamic Elastometric Body
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Turner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin Rehabil. 2009 Apr;23(4):362-70. doi: 10.1177/0269215508101742. Epub 2009 Jan 29. Erratum In: Clin Rehabil. 2010 Feb;24(2):191.
- Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
- Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
- Brown G. NICU noise and the preterm infant. Neonatal Netw. 2009 May-Jun;28(3):165-73. doi: 10.1891/0730-0832.28.3.165.
- Tognetti A, Lorussi F, Tesconi M, Bartalesi R, Zupone G, De Rossi D. Wearable kinesthetic systems for capturing and classifying body posture and gesture. Conf Proc IEEE Eng Med Biol Soc. 2005;2006:1012-5. doi: 10.1109/IEMBS.2005.1616589.
- Matthews MJ, Watson M, Richardson B. Effects of dynamic elastomeric fabric orthoses on children with cerebral palsy. Prosthet Orthot Int. 2009 Dec;33(4):339-47. doi: 10.3109/03093640903150287.
- Watson MJ, Crosby P, Matthews M. An evaluation of the effects of a dynamic lycra orthosis on arm function in a late stage patient with acquired brain injury. Brain Inj. 2007 Jun;21(7):753-61. doi: 10.1080/02699050701481613.
- Cholewicki J, Lee AS, Peter Reeves N, Morrisette DC. Comparison of trunk stiffness provided by different design characteristics of lumbosacral orthoses. Clin Biomech (Bristol, Avon). 2010 Feb;25(2):110-4. doi: 10.1016/j.clinbiomech.2009.10.010. Epub 2009 Dec 9.
- Flanagan A, Krzak J, Peer M, Johnson P, Urban M. Evaluation of short-term intensive orthotic garment use in children who have cerebral palsy. Pediatr Phys Ther. 2009 Summer;21(2):201-4. doi: 10.1097/PEP.0b013e3181a347ab.
- Harris SR. A study of a dynamic proximal stability splint in the management of children with cerebral palsy. Dev Med Child Neurol. 1996 Feb;38(2):181-3. No abstract available.
- Blair E, Ballantyne J, Horsman S, Chauvel P. A study of a dynamic proximal stability splint in the management of children with cerebral palsy. Dev Med Child Neurol. 1995 Jun;37(6):544-54. doi: 10.1111/j.1469-8749.1995.tb12041.x.
- Romeo DM, Specchia A, Sini F, Bompard S, Di Polito A, Del Vecchio A, Ferrara P, Bernabei R, Mercuri E. Effects of Lycra suits in children with cerebral palsy. Eur J Paediatr Neurol. 2018 Sep;22(5):831-836. doi: 10.1016/j.ejpn.2018.04.014. Epub 2018 May 3.
- Belizon-Bravo N, Romero-Galisteo RP, Cano-Bravo F, Gonzalez-Medina G, Pinero-Pinto E, Luque-Moreno C. Effects of Dynamic Suit Orthoses on the Spatio-Temporal Gait Parameters in Children with Cerebral Palsy: A Systematic Review. Children (Basel). 2021 Nov 5;8(11):1016. doi: 10.3390/children8111016.
- Romeo DM, Bompard S, Cocca C, Serrao F, De Carolis MP, Zuppa AA, Ricci D, Gallini F, Maddaloni C, Romagnoli C, Mercuri E. Neonatal neurological examination during the first 6h after birth. Early Hum Dev. 2017 May;108:41-44. doi: 10.1016/j.earlhumdev.2017.03.013. Epub 2017 Apr 5.
- Romeo DM, Cowan FM, Haataja L, Ricci D, Pede E, Gallini F, Cota F, Brogna C, Vento G, Romeo MG, Mercuri E. Hammersmith Infant Neurological Examination for infants born preterm: predicting outcomes other than cerebral palsy. Dev Med Child Neurol. 2021 Aug;63(8):939-946. doi: 10.1111/dmcn.14768. Epub 2020 Dec 18.
- Lester BM, Andreozzi-Fontaine L, Tronick E, Bigsby R. Assessment and evaluation of the high risk neonate: the NICU Network Neurobehavioral Scale. J Vis Exp. 2014 Aug 25;(90):3368. doi: 10.3791/3368.
- Einspieler 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.
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 (Actual)
March 1, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
July 31, 2025
Study Registration Dates
First Submitted
March 28, 2023
First Submitted That Met QC Criteria
April 26, 2023
First Posted (Actual)
April 28, 2023
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5364
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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