NCT05835765

Use of Dynamic Elastometric Body in Preterm Newborns

Use of Dynamic Elastometric Body in Preterm Newborns: A Prospective Pilot Study With a Medical Device

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 8 Days – 1 Month
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Dynamic Elastometric Body in Preterm Newborns	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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-05-01
• Completion: 2025-07-31
• First posted: 2023-04-28
• Last updated: 2024-03-06

Locations

1 site across 1 country: Italy