Use of Dynamic Elastometric Body in Preterm Newborns (BODYNEO)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Invitation-only

Conditions: Premature Birth

Treatments: Device: Dynamic Elastometric Body in Preterm Newborns

Study type: Interventional

Funder types: Other

Identifiers

NCT05835765

5364

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 8 days to 1 month old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Dynamic Elastometric Body and neurological evaluation

Experimental group

Description:

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

Treatment:

Device: Dynamic Elastometric Body in Preterm Newborns

Neurological evaluation

No Intervention group

Description:

Neurological evaluation at enrollment, at one week after enrollment and at 1th months since discharge