Application of Forced Oscillation Technique in Infancy
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Respiratory reactance (Xrs) - Term newborns
研究概览
简要总结
The aim of this study is the implementation of Forced Oscillations Technique (FOT) in newborns and small infants using a novel commercially available device.
The objective is to assess the feasibility of the method, provide normative data for the first months of life and describe short- and long-term changes in neonatal respiratory disorders.
The study population will consist of term and preterm newborns admitted to the Neonatal Intensive Care Unit (NICU) or the Well-Baby Nursery of the University Hospital of Patras, Greece. It is estimated that 200 full-term and 150 preterm newborns will be enrolled during a period of 36 months (March 2021 - September 2022).
Measurements will be performed using the TremoFlo N-100 via a face mask, with the infant in the supine position during natural sleep. At least 3 technically acceptable measurements (duration 10s each) will be obtained, as follows:
- Healthy full-term neonates: postnatal days 1, 2, 3 and at discharge
- Preterm neonates: NICU admission, postnatal days 1, 2 and 3, and on the first day of each additional gestational week until discharge
All participants will be also measured at the age of 3, 6 and 12 months.
详细描述
INTRODUCTION Pulmonary function testing during early infancy requires sophisticated equipment, specialized personnel and proper patient's preparation. As a result, lung function testing in newborns and small infants is limited to few highly specialized centers.
The forced oscillations technique (FOT) uses complex pressure signals generated by an external device at the airway opening. The pressure waves are transmitted through the airway tree during tidal breathing and force the anatomical structures of the respiratory system to oscillate. From subsequent pressure and flow signal analysis, the total resistance (Rrs) and reactance (Xrs) of the respiratory system are calculated. The latter relates mainly to the elastic properties of the lung parenchyma and the inertia of the column of air in the airways. Both Rrs and Xrs depend on the frequency of oscillation; lower frequencies (range 5-10Hz) provide information on the mechanical properties of smaller airways and vice versa. FOT measurements can be performed fast (usually in less than 30 s), at the bedside, and do not require patient's cooperation. Therefore, FOT is being viewed as an attractive and promising pulmonary function technique for young infants and newborns.
To date, the introduction of infant FOT in routine clinical practice has been limited due to lack of suitable devices and normative data. Studies based on in-build FOT equipment have shown that the application of the method in small infants is feasible. A recent study, in which a modified commercially available device (Tremoflo C-100, THORASYS Thoracic Medical Systems Inc. Montreal, Canada) was used, also supports the feasibility of the method.
OBJECTIVE The aim of this study is the implementation of FOT in newborns and small infants using a novel commercially available device (Tremoflo N-100, THORASYS), specifically released for this age range.
Our objectives are: a) to assess the feasibility of the method and the repeatability of FOT measurements in newborns and small infants, b) to provide normative data for the first months of life in relation to various parameters (e.g. gender, age, somatometrics, etc) and, c) to describe short- and long-term and Rrs and Xrs changes in neonatal respiratory disease (e.g. respiratory distress syndrome, bronchopulmonary dysplasia, etc).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns cared for in the NICU and well-baby nursery of the University Hospital of Patras, Greece.
- •Parental written informed consent.
排除标准
- •Major respiratory, cardiovascular or other condition that does not permit FOT measurements at the predetermined time points.
- •Any infectious disorder with increased risk of contamination.
- •Orofacial anomalies (e.g. genetic syndromes) that do not permit proper application of the face mask.
研究组 & 干预措施
FOT measurements
FOT measurements in newborns and small infants
干预措施: FOT measurements in newborns and small infants (Diagnostic Test)
结局指标
主要结局
Respiratory reactance (Xrs) - Term newborns
时间窗: On the day of discharge
Xrs at multiple frequencies (FOT) in term infants
Respiratory reactance (Xrs) - Infancy
时间窗: At the age of 12 months (+/- 2 weeks)
Xrs at multiple frequencies (FOT) during infancy
Respiratory resistance (Rrs) - Term newborns
时间窗: On the day of discharge.
Rrs at multiple frequencies (FOT) in term infants
Respiratory resistance (Rrs) - Preterm newborns
时间窗: On the day of discharge.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
时间窗: On the day of discharge.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Infancy
时间窗: At the age of 12 months (+/- 2 weeks)
Rrs at multiple frequencies (FOT) during infancy
Respiratory resistance (Rrs) - Term newborns
时间窗: Postnatal day 1.
Rrs at multiple frequencies (FOT) in term infants
Respiratory resistance (Rrs) - Term newborns
时间窗: Postnatal day 2.
Rrs at multiple frequencies (FOT) in term infants
Respiratory resistance (Rrs) - Term newborns
时间窗: Postnatal day 3.
Rrs at multiple frequencies (FOT) in term infants
Respiratory reactance (Xrs) - Term newborns
时间窗: Postnatal day 1.
Xrs at multiple frequencies (FOT) in term infants
Respiratory reactance (Xrs) - Term newborns
时间窗: Postnatal day 2.
Xrs at multiple frequencies (FOT) in term infants
Respiratory reactance (Xrs) - Term newborns
时间窗: Postnatal day 3.
Xrs at multiple frequencies (FOT) in term infants
Respiratory resistance (Rrs) - Preterm newborns
时间窗: At NICU admission (within the first 2 hours).
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
时间窗: Postnatal day 1.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
时间窗: Postnatal day 2.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
时间窗: Postnatal day 3.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
时间窗: On the first day of each additional week until 36 weeks post-conceptional age.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
时间窗: At NICU admission (within the first 2 hours).
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
时间窗: On postnatal day 1.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
时间窗: On postnatal day 2.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
时间窗: On postnatal day 3.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
时间窗: On the first day of each additional week until 36 weeks post-conceptional age.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Infancy
时间窗: At the age of 3 months (+/- 1 week)
Rrs at multiple frequencies (FOT) during infancy
Respiratory resistance (Rrs) - Infancy
时间窗: At the age of 6 months (+/- 1 week)
Rrs at multiple frequencies (FOT) during infancy
Respiratory reactance (Xrs) - Infancy
时间窗: At the age of 3 months (+/- 1 week)
Xrs at multiple frequencies (FOT) during infancy
Respiratory reactance (Xrs) - Infancy
时间窗: At the age of 6 months (+/- 1 week)
Xrs at multiple frequencies (FOT) during infancy
次要结局
未报告次要终点
研究者
Fouzas Sotirios
Assistant Professor of Pediatrics
University of Patras