Use of Dynamic Elastometric Body in Preterm Newborns

Not Applicable

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Dynamic Elastometric Body and neurological evaluation	Dynamic Elastometric Body in Preterm Newborns	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

Primary Outcome Measures

Name	Time	Method
Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit	at one month from hospital discharge	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)

Secondary Outcome Measures

Name	Time	Method
Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)	At one month from hospital discharge	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).	At one month from hospital discharge	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)"	At 30 minutes from the use of Dynamic Elastometric Body	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.

Locations (1): Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
🇮🇹
Rome, Italy