The NIOMI Study: Non-Invasive Lung Oxygen Monitoring of Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of infants in whom at least 1 oxygen measurement was obtained.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infant on the postnatal ward.
- •Full-term (gestational age ≥37 weeks).
- •Anticipated stay in the hospital > 1 day.
排除标准
- •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)
结局指标
主要结局
Percentage of infants in whom at least 1 oxygen measurement was obtained.
时间窗: 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
时间窗: 12 months
Describe the absorption of water vapor and molecular oxygen, by means of projected concentration, presented in percent meters (%m)
次要结局
未报告次要终点
研究者
Dr. Gene Dempsey
Professor
University College Cork