Respiratory Function TestsiFOTNCT04697251
Infant Forced Oscillations Technique (iFOT)
A study testing FOT measurements in newborns and small infants in people with Respiratory Function Tests and Respiratory Disease, run by University of Patras at 2 sites in Greece.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function Tests, Respiratory Disease, Infant, Newborn, Disease
- What is being tested?
- FOT measurements in newborns and small infants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Apr 2021to Mar 2023
- Phase
- Interventional
- 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 1 day to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns cared for in the NICU and well-baby nursery of the University Hospital of Patras, Greece.
- Parental written informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Gabriel Dimitriou, MD, PhD contact
Greece2 sites, 2 recruiting
- Recruiting
Neonatal Intensive Care Unit, University Hospital of Patras
Pátrai, 26504
Gabriel Dimitriou, MD, PhD, gdim@upatras.gr
Sotirios Fouzas, MD, PhD, 6944510047, sfouzas@upatras.gr
- Recruiting
Well-baby nursery, Department of Pediatrics, University Hospital of Patras
Pátrai, 26504
Gabriel Dimitriou, MD, PhD, gdim@upatras.gr
Sotirios Fouzas, MD, PhD, 6944510047, sfouzas@upatras.gr
About this study
Official title: Application of Forced Oscillation Technique in Infancy
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.
Read more
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.
Read the detailed description
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).
METHODS Population 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).
The parents of all infants will provide written informed consent prior to enrollment. The study has been approved by the Research and Ethics Committee of the hospital (decision no. 451/12.11.2020).
Measurements Measurements will be performed using the TremoFlo N-100, at bedside, with the infant in the supine position during quiet natural sleep. The device will be calibrated daily, according to manufacturer's instructions. After proper cleaning and decontamination, the face mask of the device will be preheated at 37oC (to avoid awakening) and will be placed on infant's face. The duration of each measurement will be predetermined at 10 s. At least 3 technically acceptable measurements will be performed per infant, with 30 s intervals between them. The validity of each measurement will be assessed according to the coherence function (automatically determined by the operating system of the device).
Protocol
FOT measurements will be scheduled according to the target population, as follows:
- In healthy full-term neonates, measurements will be obtained on postnatal days 1, 2, 3 and at discharge. Parents will be asked and scheduled to repeat testing at the age of 3, 6 and 12 months.
- In preterm neonates without respiratory disease, measurements will be performed on NICU admission, on postnatal days 1, 2 and 3, and on the first day of each additional gestational week until discharge. For example, a preterm neonate with gestational age 331/7, will be measured at 331/7, 332/7, 333/7, 334/7, 34, 35, 36, etc. Parents of preterm newborns will be also asked and scheduled to repeat testing at the age of 3, 6 and 12 months.
- In preterm neonates with respiratory distress syndrome (RDS) the measurements will be obtained on NICU admission and at 6 and 12 hours after surfactant administration. Thereafter, the same protocol with preterm neonates without respiratory disease will be applied. In mechanically ventilated infants the measurements will be performed via the endotracheal tube, but only if their clinical condition permits FOT testing. In such cases, the device will be calibrated in advance using an endotracheal tube of the same internal diameter, material and length as that positioned on the neonate.
EXPECTED RESULTS AND BENEFITS The study is expected to confirm the feasibility of FOT in newborns and small infants (in NICU or outpatient settings) and, most important, to reveal a series of technical/practical details that may improve the applicability of the method in clinical practice. Finally, the study will provide normative data for this age range, and will assess Rrs and Xrs changes in various respiratory disorders of the neonatal period and early infancy.
- Being tested
- FOT measurements in newborns and small infants
- Medical subject headings
- Respiration Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOT measurements in newborns and small infantsDiagnostic test
Measurements will be performed using the device TremoFlo N-100, at bedside, with the infant in the supine position during quiet natural sleep. After proper cleaning and decontamination, the face mask of the device will be preheated at 37oC (to avoid awakening) and will be placed on infant's face. The duration of each measurement will be predetermined at 10 s. At least 3 technically acceptable measurements will be performed per infant, with 30 s intervals between them. The validity of each measurement will be assessed according to the coherence function (automatically determined by the operating system of the device).
| Study group | Role | What they receive |
|---|---|---|
| FOT measurements | Other | FOT measurements in newborns and small infants Receives: Diagnostic Test: FOT measurements in newborns and small infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory resistance (Rrs) - Term newborns
Rrs at multiple frequencies (FOT) in term infants
Measured: Postnatal day 1.
Respiratory resistance (Rrs) - Term newborns
Rrs at multiple frequencies (FOT) in term infants
Measured: Postnatal day 2.
Respiratory resistance (Rrs) - Term newborns
Rrs at multiple frequencies (FOT) in term infants
Measured: Postnatal day 3.
Respiratory resistance (Rrs) - Term newborns
Rrs at multiple frequencies (FOT) in term infants
Measured: On the day of discharge.
Respiratory reactance (Xrs) - Term newborns
Xrs at multiple frequencies (FOT) in term infants
Measured: Postnatal day 1.
Respiratory reactance (Xrs) - Term newborns
Xrs at multiple frequencies (FOT) in term infants
Measured: Postnatal day 2.
Respiratory reactance (Xrs) - Term newborns
Xrs at multiple frequencies (FOT) in term infants
Measured: Postnatal day 3.
Respiratory reactance (Xrs) - Term newborns
Xrs at multiple frequencies (FOT) in term infants
Measured: On the day of discharge
Respiratory resistance (Rrs) - Preterm newborns
Rrs at multiple frequencies (FOT) in preterm infants
Measured: At NICU admission (within the first 2 hours).
Respiratory resistance (Rrs) - Preterm newborns
Rrs at multiple frequencies (FOT) in preterm infants
Measured: Postnatal day 1.
Respiratory resistance (Rrs) - Preterm newborns
Rrs at multiple frequencies (FOT) in preterm infants
Measured: Postnatal day 2.
Respiratory resistance (Rrs) - Preterm newborns
Rrs at multiple frequencies (FOT) in preterm infants
Measured: Postnatal day 3.
Respiratory resistance (Rrs) - Preterm newborns
Rrs at multiple frequencies (FOT) in preterm infants
Measured: On the first day of each additional week until 36 weeks post-conceptional age.
Respiratory resistance (Rrs) - Preterm newborns
Rrs at multiple frequencies (FOT) in preterm infants
Measured: On the day of discharge.
Respiratory reactance (Xrs) - Preterm newborns
Xrs at multiple frequencies (FOT) in preterm infants
Measured: At NICU admission (within the first 2 hours).
Respiratory reactance (Xrs) - Preterm newborns
Xrs at multiple frequencies (FOT) in preterm infants
Measured: On postnatal day 1.
Respiratory reactance (Xrs) - Preterm newborns
Xrs at multiple frequencies (FOT) in preterm infants
Measured: On postnatal day 2.
Respiratory reactance (Xrs) - Preterm newborns
Xrs at multiple frequencies (FOT) in preterm infants
Measured: On postnatal day 3.
Respiratory reactance (Xrs) - Preterm newborns
Xrs at multiple frequencies (FOT) in preterm infants
Measured: On the first day of each additional week until 36 weeks post-conceptional age.
Respiratory reactance (Xrs) - Preterm newborns
Xrs at multiple frequencies (FOT) in preterm infants
Measured: On the day of discharge.
Respiratory resistance (Rrs) - Infancy
Rrs at multiple frequencies (FOT) during infancy
Measured: At the age of 3 months (+/- 1 week)
Respiratory resistance (Rrs) - Infancy
Rrs at multiple frequencies (FOT) during infancy
Measured: At the age of 6 months (+/- 1 week)
Respiratory resistance (Rrs) - Infancy
Rrs at multiple frequencies (FOT) during infancy
Measured: At the age of 12 months (+/- 2 weeks)
Respiratory reactance (Xrs) - Infancy
Xrs at multiple frequencies (FOT) during infancy
Measured: At the age of 3 months (+/- 1 week)
Respiratory reactance (Xrs) - Infancy
Xrs at multiple frequencies (FOT) during infancy
Measured: At the age of 6 months (+/- 1 week)
Respiratory reactance (Xrs) - Infancy
Xrs at multiple frequencies (FOT) during infancy
Measured: At the age of 12 months (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Apr 2021
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Function TestsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouzas Sotirios, University of Patras
- Investigators
- Sotirios Fouzas, Principal investigator, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697251
- Sponsor's protocol ID
- 28292/20201103
- Acronym
- iFOT
- Status last verified
- Apr 2021
- First submitted
- 2 Jan 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Ethics Committee approval
Publications
Skylogianni E, Douros K, Anthracopoulos MB, Fouzas S. The Forced Oscillation Technique in Paediatric Respiratory Practice. Paediatr Respir Rev. 2016 Mar;18:46-51. doi: 10.1016/j.prrv.2015.11.001. Epub 2015 Nov 10.
PubMed 26777151Hantos Z, Czovek D, Gyurkovits Z, Szabo H, Maar BA, Radics B, Virag K, Makan G, Orvos H, Gingl Z, Sly PD. Assessment of respiratory mechanics with forced oscillations in healthy newborns. Pediatr Pulmonol. 2015 Apr;50(4):344-52. doi: 10.1002/ppul.23103. Epub 2014 Aug 25.
PubMed 25154334Gray DM, Czovek D, McMillan L, Turkovic L, Stadler JAM, Vanker A, Radics BL, Gingl Z, Hall GL, Sly PD, Zar HJ, Hantos Z. Intra-breath measures of respiratory mechanics in healthy African infants detect risk of respiratory illness in early life. Eur Respir J. 2019 Jan 31;53(2):1800998. doi: 10.1183/13993003.00998-2018. Print 2019 Feb.
PubMed 30464010Klinger AP, Travers CP, Martin A, Kuo HC, Alishlash AS, Harris WT, Carlo WA, Ambalavanan N. Non-invasive forced oscillometry to quantify respiratory mechanics in term neonates. Pediatr Res. 2020 Aug;88(2):293-299. doi: 10.1038/s41390-020-0751-7. Epub 2020 Jan 14.
PubMed 31935746
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Forced Oscillation Technique in Infancy
- ClinicalTrials.gov ID
- NCT04697251
- Acronym / sponsor ID
- iFOT / 28292/20201103
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 6 Jan 2021 (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.
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.
Detailed description
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).
METHODS Population 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).
The parents of all infants will provide written informed consent prior to enrollment. The study has been approved by the Research and Ethics Committee of the hospital (decision no. 451/12.11.2020).
Measurements Measurements will be performed using the TremoFlo N-100, at bedside, with the infant in the supine position during quiet natural sleep. The device will be calibrated daily, according to manufacturer's instructions. After proper cleaning and decontamination, the face mask of the device will be preheated at 37oC (to avoid awakening) and will be placed on infant's face. The duration of each measurement will be predetermined at 10 s. At least 3 technically acceptable measurements will be performed per infant, with 30 s intervals between them. The validity of each measurement will be assessed according to the coherence function (automatically determined by the operating system of the device).
Protocol
FOT measurements will be scheduled according to the target population, as follows:
- In healthy full-term neonates, measurements will be obtained on postnatal days 1, 2, 3 and at discharge. Parents will be asked and scheduled to repeat testing at the age of 3, 6 and 12 months.
- In preterm neonates without respiratory disease, measurements will be performed on NICU admission, on postnatal days 1, 2 and 3, and on the first day of each additional gestational week until discharge. For example, a preterm neonate with gestational age 331/7, will be measured at 331/7, 332/7, 333/7, 334/7, 34, 35, 36, etc. Parents of preterm newborns will be also asked and scheduled to repeat testing at the age of 3, 6 and 12 months.
- In preterm neonates with respiratory distress syndrome (RDS) the measurements will be obtained on NICU admission and at 6 and 12 hours after surfactant administration. Thereafter, the same protocol with preterm neonates without respiratory disease will be applied. In mechanically ventilated infants the measurements will be performed via the endotracheal tube, but only if their clinical condition permits FOT testing. In such cases, the device will be calibrated in advance using an endotracheal tube of the same internal diameter, material and length as that positioned on the neonate.
EXPECTED RESULTS AND BENEFITS The study is expected to confirm the feasibility of FOT in newborns and small infants (in NICU or outpatient settings) and, most important, to reveal a series of technical/practical details that may improve the applicability of the method in clinical practice. Finally, the study will provide normative data for this age range, and will assess Rrs and Xrs changes in various respiratory disorders of the neonatal period and early infancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOT measurements | Other | Diagnostic Test: FOT measurements in newborns and small infantsFOT measurements in newborns and small infants |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborns cared for in the NICU and well-baby nursery of the University Hospital of Patras, Greece.
- Parental written informed consent.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| FOT measurements in newborns and small infantsMeasurements will be performed using the device TremoFlo N-100, at bedside, with the infant in the supine position during quiet natural sleep. After proper cleaning and decontamination, the face mask of the device will be preheated at 37oC (to avoid awakening) and will be placed on infant's face. The duration of each measurement will be predetermined at 10 s. At least 3 technically acceptable measurements will be performed per infant, with 30 s intervals between them. The validity of each measurement will be assessed according to the coherence function (automatically determined by the operating system of the device). | Diagnostic test | FOT measurements |
Primary outcome
Respiratory resistance (Rrs) - Term newborns
Time frame: Postnatal day 1.
Rrs at multiple frequencies (FOT) in term infants
Respiratory resistance (Rrs) - Term newborns
Time frame: Postnatal day 2.
Rrs at multiple frequencies (FOT) in term infants
Respiratory resistance (Rrs) - Term newborns
Time frame: Postnatal day 3.
Rrs at multiple frequencies (FOT) in term infants
Respiratory resistance (Rrs) - Term newborns
Time frame: On the day of discharge.
Rrs at multiple frequencies (FOT) in term infants
Respiratory reactance (Xrs) - Term newborns
Time frame: Postnatal day 1.
Xrs at multiple frequencies (FOT) in term infants
Respiratory reactance (Xrs) - Term newborns
Time frame: Postnatal day 2.
Xrs at multiple frequencies (FOT) in term infants
Respiratory reactance (Xrs) - Term newborns
Time frame: Postnatal day 3.
Xrs at multiple frequencies (FOT) in term infants
Respiratory reactance (Xrs) - Term newborns
Time frame: On the day of discharge
Xrs at multiple frequencies (FOT) in term infants
Respiratory resistance (Rrs) - Preterm newborns
Time frame: At NICU admission (within the first 2 hours).
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
Time frame: Postnatal day 1.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
Time frame: Postnatal day 2.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
Time frame: Postnatal day 3.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
Time frame: On the first day of each additional week until 36 weeks post-conceptional age.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Preterm newborns
Time frame: On the day of discharge.
Rrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
Time frame: At NICU admission (within the first 2 hours).
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
Time frame: On postnatal day 1.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
Time frame: On postnatal day 2.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
Time frame: On postnatal day 3.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
Time frame: On the first day of each additional week until 36 weeks post-conceptional age.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory reactance (Xrs) - Preterm newborns
Time frame: On the day of discharge.
Xrs at multiple frequencies (FOT) in preterm infants
Respiratory resistance (Rrs) - Infancy
Time frame: At the age of 3 months (+/- 1 week)
Rrs at multiple frequencies (FOT) during infancy
Respiratory resistance (Rrs) - Infancy
Time frame: At the age of 6 months (+/- 1 week)
Rrs at multiple frequencies (FOT) during infancy
Respiratory resistance (Rrs) - Infancy
Time frame: At the age of 12 months (+/- 2 weeks)
Rrs at multiple frequencies (FOT) during infancy
Respiratory reactance (Xrs) - Infancy
Time frame: At the age of 3 months (+/- 1 week)
Xrs at multiple frequencies (FOT) during infancy
Respiratory reactance (Xrs) - Infancy
Time frame: At the age of 6 months (+/- 1 week)
Xrs at multiple frequencies (FOT) during infancy
Respiratory reactance (Xrs) - Infancy
Time frame: At the age of 12 months (+/- 2 weeks)
Xrs at multiple frequencies (FOT) during infancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 26777151Skylogianni E, Douros K, Anthracopoulos MB, Fouzas S. The Forced Oscillation Technique in Paediatric Respiratory Practice. Paediatr Respir Rev. 2016 Mar;18:46-51. doi: 10.1016/j.prrv.2015.11.001. Epub 2015 Nov 10.
- Background: PubMed 25154334Hantos Z, Czovek D, Gyurkovits Z, Szabo H, Maar BA, Radics B, Virag K, Makan G, Orvos H, Gingl Z, Sly PD. Assessment of respiratory mechanics with forced oscillations in healthy newborns. Pediatr Pulmonol. 2015 Apr;50(4):344-52. doi: 10.1002/ppul.23103. Epub 2014 Aug 25.
- Background: PubMed 30464010Gray DM, Czovek D, McMillan L, Turkovic L, Stadler JAM, Vanker A, Radics BL, Gingl Z, Hall GL, Sly PD, Zar HJ, Hantos Z. Intra-breath measures of respiratory mechanics in healthy African infants detect risk of respiratory illness in early life. Eur Respir J. 2019 Jan 31;53(2):1800998. doi: 10.1183/13993003.00998-2018. Print 2019 Feb.
- Background: PubMed 31935746Klinger AP, Travers CP, Martin A, Kuo HC, Alishlash AS, Harris WT, Carlo WA, Ambalavanan N. Non-invasive forced oscillometry to quantify respiratory mechanics in term neonates. Pediatr Res. 2020 Aug;88(2):293-299. doi: 10.1038/s41390-020-0751-7. Epub 2020 Jan 14.
- Individual participant dataSharing planned: No. No Ethics Committee approval
Related trials for Respiratory Function Tests
Not yet recruiting
Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function
Cystic Fibrosis
RecruitingObservational study
Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community Settings
COPD (Chronic Obstructive Pulmonary Disease), Airway Disease
Recruiting
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Interstitial Lung Disease (ILD), Suspected Interstitial Lung Disease
Active, not recruiting
Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease
Not yet recruiting
Testing the Effects of Temperature & Humidity on Children With and Without Asthma in an Environmental Climatic Chamber
Asthma
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.
Gabriel Dimitriou, MD, PhD contact
Sotirios Fouzas principal investigator
University of Patras
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOT measurements in newborns and small infants in people with Respiratory Function Tests and Respiratory Disease, run by University of Patras at 2 sites in Greece.
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 2 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sotirios Fouzas, MD, PhD (6944510047, sfouzas@upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory resistance (Rrs) - Term newborns (time frame: Postnatal day 1.). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04697251, which also lists 4 linked publications.
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 28 Apr 2021.