Use of Dynamic Elastometric Body in Preterm Newborns

Premature Birth Clinical Trial

— BODYNEO  

Official title:

Use of Dynamic Elastometric Body in Preterm Newborns: A Prospective Pilot Study With a Medical Device

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05835765
• Other study ID #: 5364
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: July 31, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Days to 1 Month

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth

Intervention

Device:
• Dynamic Elastometric Body in Preterm Newborns
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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli -IRRCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit	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
Primary	Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit	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
Primary	Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit	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	Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)	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
Secondary	Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)	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
Secondary	Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)	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
Secondary	Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).	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
Secondary	Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).	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
Secondary	Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).	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
Secondary	Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"	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
Secondary	Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"	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
Secondary	Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"	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
Secondary	Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"	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