Use of Dynamic Elastometric Body in Preterm Newborns: A Prospective Pilot Study With a Medical Device
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 8 Days to 1 Month (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Dynamic Elastometric Body and 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
Intervention: Dynamic Elastometric Body in Preterm Newborns (Device)
Neurological evaluation
Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge
Outcomes
Primary Outcomes
Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
Time Frame: 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)
Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
Time Frame: baseline
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)
Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
Time Frame: One week of application of Dynamic Elastometric Body
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 Outcomes
- Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)(At one month from hospital discharge)
- Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).(At one month from hospital discharge)
- Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"(At 30 minutes from the use of Dynamic Elastometric Body)
- Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)(baseline)
- Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)(One week after the use of Dynamic Elastometric Body)
- Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).(baseline)
- Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).(One week after the use of Dynamic Elastometric Body)
- Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"(baseline)
- Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"(One week after the use of Dynamic Elastometric Body)
- Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"(At one month from hospital discharge)
Investigators
Romeo Domenico Marco
Assistant professor, Principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS