Lung DiseasesNIOMINCT05851638
The NIOMI Study: Non-Invasive Lung Oxygen Monitoring of Term Infants
An observational study of Lung Diseases, run by University College Cork at 1 site in Ireland.
Trial summary
Infants born prematurely e.g. 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. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Lung Oxygen measurement with GASMAS system
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Nov 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Random parents will be approached on the postnatal ward during working day hours by one of the research team members. The measurements will be performed on full-term, healthy infants after parental consent has been obtained.
Who may be able to join
- Healthy infant on the postnatal ward.
- Full-term (gestational age ≥37 weeks).
- Anticipated stay in the hospital > 1 day.
Who cannot join
- Parent/guardian unable to/declined to participate in the study.
- The baby was admitted to the Neonatal Unit.
- Presence of congenital cardiac anomalies (report of antenatal scans from patient electronic record chart)
Trial locations and contacts
1 site in 1 country.
About this study
Infants born prematurely e.g. 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 baby's torso.
Read the 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 infant's armpit and the light source probe placed at the locations indicated below:
- 2nd intercostal space in midclavicular line;
- 4th intercostal space in midclavicular line (beside the level of nipple);
- 6th intercostal space in midclavicular line;
- 1.5 cm below detector probe in midaxillary line;
- 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 infant's 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 UL/EN/IEC and FCC Part 15 Class A specifications for enhanced patient safety. The medical cart is environmentally clean with RoHS, REACH, WEEE and EU (94/62/EC) packaging compliance.
- Conditions
- Lung Diseases
- Being tested
- Lung Oxygen measurement with GASMAS system
- Keywords
- lungs, oxygen, GASMAS, Spectroscopy, neonate
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Oxygen measurement with GASMAS systemDevice
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 to measure lung oxygen.
| Study group | Role | What they receive |
|---|---|---|
| Healthy term neonates | Inclusion criteria for participant selection are:
* Healthy infant on postnatal ward.
* Full term (gestational age ≥37 weeks).
* Anticipated stay in the hospital > 1 day.
Exclusion criteria for participant selection are:
* Parent/guardian unable to/decline to participate in the study.
* Baby admitted to the Neonatal Unit.
* Presence of congenital cardiac anomalies (report of antenatal scans from patient electronic record chart). Receives: Device: Lung Oxygen measurement with GASMAS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of infants in whom at least 1 oxygen measurement was obtained.
The primary outcome will be the percentage of infants in whom at least 1 oxygen measurement was obtained where the signal-to-noise ratio was greater than 3.
Measured: 12 months
Projected concentration in percent meters
Describe the absorption of water vapor and molecular oxygen, by means of projected concentration, presented in percent meters (%m)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Nov 2021
- Primary completion3 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Tyndall National Institute
- Responsible party
- Principal investigator, Dr. Gene Dempsey, University College Cork
- Investigators
- Eugene Dempsey, Professor, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851638
- Sponsor's protocol ID
- 12 MAY 2020/Version 1.0
- Acronym
- NIOMI
- Status last verified
- May 2023
- First submitted
- 25 Jan 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NIOMI Study: Non-Invasive Lung Oxygen Monitoring of Term Infants
- ClinicalTrials.gov ID
- NCT05851638
- Acronym / sponsor ID
- NIOMI / 12 MAY 2020/Version 1.0
- Conditions
- Lung Diseases
- Keywords
- lungs, oxygen, GASMAS, Spectroscopy, neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Tyndall National Institute
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infants born prematurely e.g. 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 baby's 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 infant's armpit and the light source probe placed at the locations indicated below:
- 2nd intercostal space in midclavicular line;
- 4th intercostal space in midclavicular line (beside the level of nipple);
- 6th intercostal space in midclavicular line;
- 1.5 cm below detector probe in midaxillary line;
- 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 infant's 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 UL/EN/IEC and FCC Part 15 Class A specifications for enhanced patient safety. The medical cart is environmentally clean with RoHS, REACH, WEEE and EU (94/62/EC) packaging compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy term neonates | – | Device: Lung Oxygen measurement with GASMAS systemInclusion criteria for participant selection are: * Healthy infant on postnatal ward. * Full term (gestational age ≥37 weeks). * Anticipated stay in the hospital > 1 day. Exclusion criteria for participant selection are: * Parent/guardian unable to/decline to participate in the study. * Baby admitted to the Neonatal Unit. * Presence of congenital cardiac anomalies (report of antenatal scans from patient electronic record chart). |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Random parents will be approached on the postnatal ward during working day hours by one of the research team members. The measurements will be performed on full-term, healthy infants after parental consent has been obtained.
Key inclusion criteria (3 listed)
- Healthy infant on the postnatal ward.
- Full-term (gestational age ≥37 weeks).
- Anticipated stay in the hospital > 1 day.
Key exclusion criteria (3 listed)
- Parent/guardian unable to/declined to participate in the study.
- The baby was admitted to the Neonatal Unit.
- Presence of congenital cardiac anomalies (report of antenatal scans from patient electronic record chart)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Oxygen measurement with GASMAS systemA 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 to measure lung oxygen. | Device | Healthy term neonates |
Primary outcome
Percentage of infants in whom at least 1 oxygen measurement was obtained.
Time frame: 12 months
The primary outcome will be the percentage of infants in whom at least 1 oxygen measurement was obtained where the signal-to-noise ratio was greater than 3.
Projected concentration in percent meters
Time frame: 12 months
Describe the absorption of water vapor and molecular oxygen, by means of projected concentration, presented in percent meters (%m)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Dempsey, Professor principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of infants in whom at least 1 oxygen measurement was obtained. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.