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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Elastometric Body and neurological evaluation | Experimental | 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 | No Intervention | Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Elastometric Body in Preterm Newborns | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Neurological Outcome with Hammersmith neonatal neurological examination (HNNE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli -IRRCS | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17282358 | Background | 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. | |
| 19961295 | Background | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
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) | 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). | 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). | 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). | 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)" | 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)" | 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)" | 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)" | 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 |
| 17653949 | Background | 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. |
| 20004503 | Background | Cholewicki J, Lee AS, Peter Reeves N, Morrisette DC. Comparison of trunk stiffness provided by different design characteristics of lumbosacral orthoses. Clin Biomech (Bristol). 2010 Feb;25(2):110-4. doi: 10.1016/j.clinbiomech.2009.10.010. Epub 2009 Dec 9. |
| 19440130 | Background | 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. |
| 8603786 | Background | 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. |
| 7789663 | Background | 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. |
| 29802022 | Background | 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. |
| 34828729 | Background | 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. |
| 28390243 | Background | 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. |
| 15060237 | Background | 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. |
| 8413140 | Background | 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. |
| 33336801 | Background | 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. |
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| D000091642 | Urogenital Diseases |