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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Premature Birth
Drug/Device/Intervention
Dynamic Elastometric Body in Preterm Newborns
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location
Rome, Italy
Timeline & enrollment
Phase
N/A
Start date
May 01, 2023
End date
Jul 31, 2024
Enrollment
24 participants
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
Fetus and newborn affected by precipitate deliveryPreterm delivery without spontaneous labourDisorders related to short gestation and low birth weight, not elsewhere classifiedOther preterm infantsPreterm spontaneous labour with preterm delivery
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05835765
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05835765 through Pure Global AI's free database. This phase not specified trial is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and is currently Not yet recruiting. The study focuses on Premature Birth. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.