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The NIOMI Study: Non-Invasive Lung Oxygen Monitoring of Term Infants

NCT05851638 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-05-10

No results posted yet for this study

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. 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.

Conditions

  • Lung Diseases

Interventions

DEVICE

Lung Oxygen measurement with GASMAS system

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.

Sponsors & Collaborators

  • Tyndall National Institute

    collaborator UNKNOWN

  • University College Cork

    lead OTHER

Principal Investigators

  • Eugene Dempsey, Professor · University College Cork

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-06-03
Completion
2022-08-01

Countries

  • Ireland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851638 on ClinicalTrials.gov