Use of Dynamic Elastometric Body in Preterm Newborns (BODYNEO)
Premature Birth
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
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
Experimental
No Intervention
Dynamic Elastometric Body and neurological evaluation
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
Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge