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

NCT05851638 | Completed

• 1 other identifier: 12 MAY 2020/Version 1.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lungs; oxygen; GASMAS; Spectroscopy; neonate

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  12 months

Study Arms (1)

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).

Device: Lung Oxygen measurement with GASMAS system

Interventions

Lung Oxygen measurement with GASMAS system DEVICE

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.

Healthy term neonates

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Healthy infant on the postnatal ward.
• Full-term (gestational age ≥37 weeks).
• Anticipated stay in the hospital \> 1 day.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College Cork: lead
• Tyndall National Institute: collaborator

Study Sites (1)

Cork University Maternity Hospital

Cork, Ireland

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Eugene Dempsey, Professor

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: May 10, 2023
• Study Start: November 1, 2021
• Primary Completion: June 3, 2022
• Study Completion: August 1, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

IE (1)