Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851638
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2023-01-25
Brief Title:
The NIOMI Study Non-Invasive Lung Oxygen Monitoring of Term Infants
Sponsor:
University College Cork
Organization:
University College Cork
Study Overview
Official Title:
The NIOMI Study Non-Invasive Lung Oxygen Monitoring of Term Infants
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIOMI
Brief Summary:
Infants born prematurely eg before 28 weeks of gestational age have a 50 chance of developing neonatal respiratory distress syndrome NRDS The management of NRDS is currently driven by information obtained from a sampling of arterial blood pulse oximetry and x-ray imaging On the other hand these tests carry short and long-term negative outcomes for vulnerable patients Optical technology has been developed to evaluate lung function non-invasively and without any potential risks for the patients It is based on Gas in Scattering Media Absorbance Spectroscopy GASMAS method using low-power laser light and a photodetector attached directly to the babys torso
Detailed Description:
The purpose of this observational study is to test a non-invasive optical system designed to directly measure the oxygen within the lungs of neonates using a GASMAS system NEOLA-alpha 2 GPX medical The findings of this study will generate the necessary information that will be used to guide the development of the GASMAS-based systems for future clinical adaptation in preterm infants
Subjects The measurements will be performed on full-term gestational age 37 weeks healthy infants after parental consent has been obtained
Number of participants to be recruited 100
Data collection This will be a prospective study Relevant data will be collected from maternal and neonatal electronic chart records
Procedure A specially designed light source probe 2x2cm size with 2x incorporated laser sources and a detector probe 2x2cm size will be attached to the torso of the infant in a total of 10 locations 5 for the left side of the chest and 5 for the right side to measure lung oxygen
Locations of the probes The measurements will be recorded with the detector probe placed in the infants armpit and the light source probe placed at the locations indicated below
1 2nd intercostal space in midclavicular line
2 4th intercostal space in midclavicular line beside the level of nipple
3 6th intercostal space in midclavicular line
4 15 cm below detector probe in midaxillary line
5 parasternally beside inferior angle of scapula
Duration A single optical measurement lasts approximately 2 minutes The entire measurement session will be aimed to be completed in 30 minutes Same measurements will be obtained daily until baby will be discharged from the hospital
Special conditions This is a painless procedure that should not carry any risks for the baby
Location Procedure will be performed in a separate monitoring room on the postnatal ward in Cork University Maternity hospital CUMH where parental and infant comfort as well as appropriate handling of technique can be ensured
Safety measures Materials The components of the GASMAS system that will be in contact with the infants skin have been fabricated from non-toxic materials They were also designed to be as comfortable as possible without any sharp corners or features
Eye safety The emission from the light source probe at all wavelengths is weak and diffuse and falls under Laser Class I category Lasers of this category are considered safe and present no hazard to the eye or the skin under direct exposure There is no need to wear any eye protection for anyone involved in the measurements
Electrical safety The system is well shielded and safe to use Leak currents are tested according to standard 60601 The system has been tested to comply with Radiated Emission Test according to standard EN 55032 Class A
Mechanical safety The medical cart is tested to ULENIEC and FCC Part 15 Class A specifications for enhanced patient safety The medical cart is environmentally clean with RoHS REACH WEEE and EU 9462EC packaging compliance
Subjects The measurements will be performed on full-term gestational age 37 weeks healthy infants after parental consent has been obtained
Number of participants to be recruited 100
Data collection This will be a prospective study Relevant data will be collected from maternal and neonatal electronic chart records
Procedure A specially designed light source probe 2x2cm size with 2x incorporated laser sources and a detector probe 2x2cm size will be attached to the torso of the infant in a total of 10 locations 5 for the left side of the chest and 5 for the right side to measure lung oxygen
Locations of the probes The measurements will be recorded with the detector probe placed in the infants armpit and the light source probe placed at the locations indicated below
1 2nd intercostal space in midclavicular line
2 4th intercostal space in midclavicular line beside the level of nipple
3 6th intercostal space in midclavicular line
4 15 cm below detector probe in midaxillary line
5 parasternally beside inferior angle of scapula
Duration A single optical measurement lasts approximately 2 minutes The entire measurement session will be aimed to be completed in 30 minutes Same measurements will be obtained daily until baby will be discharged from the hospital
Special conditions This is a painless procedure that should not carry any risks for the baby
Location Procedure will be performed in a separate monitoring room on the postnatal ward in Cork University Maternity hospital CUMH where parental and infant comfort as well as appropriate handling of technique can be ensured
Safety measures Materials The components of the GASMAS system that will be in contact with the infants skin have been fabricated from non-toxic materials They were also designed to be as comfortable as possible without any sharp corners or features
Eye safety The emission from the light source probe at all wavelengths is weak and diffuse and falls under Laser Class I category Lasers of this category are considered safe and present no hazard to the eye or the skin under direct exposure There is no need to wear any eye protection for anyone involved in the measurements
Electrical safety The system is well shielded and safe to use Leak currents are tested according to standard 60601 The system has been tested to comply with Radiated Emission Test according to standard EN 55032 Class A
Mechanical safety The medical cart is tested to ULENIEC and FCC Part 15 Class A specifications for enhanced patient safety The medical cart is environmentally clean with RoHS REACH WEEE and EU 9462EC packaging compliance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None