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Use of Dynamic Elastometric Body in Preterm Newborns (BODYNEO)

Primary Purpose

Premature Birth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dynamic Elastometric Body in Preterm Newborns
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth focused on measuring prematurity, Hyperexcitability syndrome, Neonatal intensive care, Dynamic Elastometric device

Eligibility Criteria

8 Days - 1 Month (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione Policlinico Universitario Agostino Gemelli -IRRCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dynamic Elastometric Body and neurological evaluation

Neurological evaluation

Arm Description

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

Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge

Outcomes

Primary Outcome Measures

Effectiveness of the Use of Dynamic Elastometric Body
Evaluation of the effectiveness of use of Dynamic Elastometric Body 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)
Effectiveness of the Use of Dynamic Elastometric Body
Evaluation of the effectiveness of use of Dynamic Elastometric Body 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)
Effectiveness of the Use of Dynamic Elastometric Body
Evaluation of the effectiveness of use of Dynamic Elastometric Body 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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 28, 2023
Last Updated
April 26, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05835765
Brief Title
Use of Dynamic Elastometric Body in Preterm Newborns
Acronym
BODYNEO
Official Title
Use of Dynamic Elastometric Body in Preterm Newborns: A Prospective Pilot Study With a Medical Device
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
prematurity, Hyperexcitability syndrome, Neonatal intensive care, Dynamic Elastometric device

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dynamic Elastometric Body and neurological evaluation
Arm Type
Experimental
Arm Description
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
Arm Title
Neurological evaluation
Arm Type
No Intervention
Arm Description
Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge
Intervention Type
Device
Intervention Name(s)
Dynamic Elastometric Body in Preterm Newborns
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of the Use of Dynamic Elastometric Body
Description
Evaluation of the effectiveness of use of Dynamic Elastometric Body 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)
Time Frame
baseline
Title
Effectiveness of the Use of Dynamic Elastometric Body
Description
Evaluation of the effectiveness of use of Dynamic Elastometric Body 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)
Time Frame
One week of application of Dynamic Elastometric Body
Title
Effectiveness of the Use of Dynamic Elastometric Body
Description
Evaluation of the effectiveness of use of Dynamic Elastometric Body 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).
Time Frame
at one month from hospital discharge
Secondary Outcome Measure Information:
Title
Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
Description
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.
Time Frame
baseline
Title
Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
Description
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.
Time Frame
One week after the use of Dynamic Elastometric Body
Title
Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
Description
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.
Time Frame
At one month from hospital discharge
Title
Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
Description
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.
Time Frame
baseline
Title
Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
Description
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.
Time Frame
One week after the use of Dynamic Elastometric Body
Title
Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
Description
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.
Time Frame
At one month from hospital discharge
Title
Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
Description
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.
Time Frame
baseline
Title
Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
Description
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.
Time Frame
One week after the use of Dynamic Elastometric Body
Title
Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
Description
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.
Time Frame
At one month from hospital discharge
Title
Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
Description
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.
Time Frame
At 30 minutes from the use of Dynamic Elastometric Body

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Days
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico M Romeo, MD,PHD
Phone
+390630156391
Email
domenicomarco.romeo@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17282358
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.
Results Reference
background
PubMed Identifier
19961295
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.
Results Reference
background
PubMed Identifier
17653949
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.
Results Reference
background
PubMed Identifier
20004503
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.
Results Reference
background
PubMed Identifier
19440130
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.
Results Reference
background
PubMed Identifier
8603786
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.
Results Reference
background
PubMed Identifier
7789663
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.
Results Reference
background
PubMed Identifier
29802022
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.
Results Reference
background
PubMed Identifier
34828729
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.
Results Reference
background
PubMed Identifier
28390243
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.
Results Reference
background
PubMed Identifier
15060237
Citation
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.
Results Reference
background
PubMed Identifier
8413140
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.
Results Reference
background
PubMed Identifier
33336801
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.
Results Reference
background
PubMed Identifier
19179355
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.
Results Reference
background
PubMed Identifier
19451078
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.
Results Reference
background
PubMed Identifier
25177897
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.
Results Reference
background
PubMed Identifier
15856440
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.
Results Reference
background

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Use of Dynamic Elastometric Body in Preterm Newborns

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