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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
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.
Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
Rome, Italy
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)
Time frame: 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)
Time frame: 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)
Time frame: at one month from hospital discharge
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 30 minutes from the use of Dynamic Elastometric Body
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