An interventional study of Dynamic Elastometric Body in Preterm Newborns in Premature Birth, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Enrolling by invitation at 1 site in Italy. Open to participants aged 8 Days to 1 Month. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Supportive care
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:
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 24 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge
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.
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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Fondazione Policlinico Universitario Agostino Gemelli IRCCS