Use of Dynamic Elastometric Body in Preterm Newborns - Trial NCT05835765

Timeline & Enrollment

Primary Outcome

Effectiveness of the Use of Dynamic Elastometric Body,Effectiveness of the Use of Dynamic Elastometric Body,Effectiveness of the Use of Dynamic Elastometric Body

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.

ICD-10 Classifications