Use of Dynamic Elastometric Body in Preterm Newborns

NCT05835765 | Enrolling By Invitation

• 1 other identifier: 5364
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

prematurity; Hyperexcitability syndrome; Neonatal intensive care; Dynamic Elastometric device

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  at one month from hospital discharge

Secondary Outcomes (10)

• 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

• Neurological Outcome with Hammersmith neonatal neurological examination (HNNE)

  At one month from hospital discharge

• 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

Study Arms (2)

Dynamic Elastometric Body and neurological evaluation

EXPERIMENTAL

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

NO INTERVENTION

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

Interventions

Dynamic Elastometric Body in Preterm Newborns DEVICE

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.

Dynamic Elastometric Body and neurological evaluation

Eligibility Criteria

• Age: 8 Days - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli -IRRCS

Rome, 00168, Italy

Location

Related Publications (17)

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MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Principal investigator

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 28, 2023
• Study Start: March 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 31, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

IT (1)