Clinical trial NCT05835765: Use of Dynamic Elastometric Body in Preterm Newborns
Official title: Use of Dynamic Elastometric Body in Preterm Newborns: A Prospective Pilot Study With a Medical Device
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Premature Birth
Keywords: prematurity
Hyperexcitability syndrome
Neonatal intensive care
Dynamic Elastometric device
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
timeFrame: baseline
measure: Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
timeFrame: One week of application of Dynamic Elastometric Body
measure: Modification or reduction of hyperexcitability syndrome with the use of Dynamic Elastometric Bodysuit
timeFrame: at one month from hospital discharge
Secondary outcomes:
measure: Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
timeFrame: baseline
measure: Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
timeFrame: One week after the use of Dynamic Elastometric Body
measure: Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)
timeFrame: At one month from hospital discharge
measure: Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
timeFrame: baseline
measure: Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
timeFrame: One week after the use of Dynamic Elastometric Body
measure: Neurobehavioural Outcome with NICU Network Neurobehavioural Scale (NNNS).
timeFrame: At one month from hospital discharge
measure: Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
timeFrame: baseline
measure: Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
timeFrame: One week after the use of Dynamic Elastometric Body
measure: Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
timeFrame: At one month from hospital discharge
measure: Neurological Outcome with "Prechtl's Assessment of General Movements (GMs)"
timeFrame: At 30 minutes from the use of Dynamic Elastometric Body
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli -IRRCS
Study officials:
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