Use of Dynamic Elastometric Body in Preterm Newborns

Study Overview
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Brief Summary
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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: 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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Device: Dynamic Elastometric Body in Preterm Newborns


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Days
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic Elastometric Body and neurological evaluation<br>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 | Device: Dynamic Elastometric Body in Preterm Newborns<br>* 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.<br>|
| No Intervention: Neurological evaluation<br>Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | baseline | 
| 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) | One week of application of Dynamic Elastometric Body | 
| 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). | at one month from hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prematurity, Hyperexcitability syndrome, Neonatal intensive care, Dynamic Elastometric device