Respiratory Disease Clinical Trial
— iFOTOfficial 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. 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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | March 2023 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 12 Months |
Eligibility | Inclusion Criteria: - Newborns cared for in the NICU and well-baby nursery of the University Hospital of Patras, Greece. - Parental written informed consent. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Greece | Neonatal Intensive Care Unit, University Hospital of Patras | Patras | |
Greece | Well-baby nursery, Department of Pediatrics, University Hospital of Patras | Patras |
Lead Sponsor | Collaborator |
---|---|
University of Patras |
Greece,
Gray 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). pii: 1800998. doi: 10.1183/13993003.00998-2018. Print 2019 Feb. — View Citation
Hantos Z, Czövek D, Gyurkovits Z, Szabó H, Maár BA, Radics B, Virág 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. — View Citation
Klinger 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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory resistance (Rrs) - Term newborns | Rrs at multiple frequencies (FOT) in term infants | Postnatal day 1. | |
Primary | Respiratory resistance (Rrs) - Term newborns | Rrs at multiple frequencies (FOT) in term infants | Postnatal day 2. | |
Primary | Respiratory resistance (Rrs) - Term newborns | Rrs at multiple frequencies (FOT) in term infants | Postnatal day 3. | |
Primary | Respiratory resistance (Rrs) - Term newborns | Rrs at multiple frequencies (FOT) in term infants | On the day of discharge. | |
Primary | Respiratory reactance (Xrs) - Term newborns | Xrs at multiple frequencies (FOT) in term infants | Postnatal day 1. | |
Primary | Respiratory reactance (Xrs) - Term newborns | Xrs at multiple frequencies (FOT) in term infants | Postnatal day 2. | |
Primary | Respiratory reactance (Xrs) - Term newborns | Xrs at multiple frequencies (FOT) in term infants | Postnatal day 3. | |
Primary | Respiratory reactance (Xrs) - Term newborns | Xrs at multiple frequencies (FOT) in term infants | On the day of discharge | |
Primary | Respiratory resistance (Rrs) - Preterm newborns | Rrs at multiple frequencies (FOT) in preterm infants | At NICU admission (within the first 2 hours). | |
Primary | Respiratory resistance (Rrs) - Preterm newborns | Rrs at multiple frequencies (FOT) in preterm infants | Postnatal day 1. | |
Primary | Respiratory resistance (Rrs) - Preterm newborns | Rrs at multiple frequencies (FOT) in preterm infants | Postnatal day 2. | |
Primary | Respiratory resistance (Rrs) - Preterm newborns | Rrs at multiple frequencies (FOT) in preterm infants | Postnatal day 3. | |
Primary | Respiratory resistance (Rrs) - Preterm newborns | Rrs at multiple frequencies (FOT) in preterm infants | On the first day of each additional week until 36 weeks post-conceptional age. | |
Primary | Respiratory resistance (Rrs) - Preterm newborns | Rrs at multiple frequencies (FOT) in preterm infants | On the day of discharge. | |
Primary | Respiratory reactance (Xrs) - Preterm newborns | Xrs at multiple frequencies (FOT) in preterm infants | At NICU admission (within the first 2 hours). | |
Primary | Respiratory reactance (Xrs) - Preterm newborns | Xrs at multiple frequencies (FOT) in preterm infants | On postnatal day 1. | |
Primary | Respiratory reactance (Xrs) - Preterm newborns | Xrs at multiple frequencies (FOT) in preterm infants | On postnatal day 2. | |
Primary | Respiratory reactance (Xrs) - Preterm newborns | Xrs at multiple frequencies (FOT) in preterm infants | On postnatal day 3. | |
Primary | Respiratory reactance (Xrs) - Preterm newborns | Xrs at multiple frequencies (FOT) in preterm infants | On the first day of each additional week until 36 weeks post-conceptional age. | |
Primary | Respiratory reactance (Xrs) - Preterm newborns | Xrs at multiple frequencies (FOT) in preterm infants | On the day of discharge. | |
Primary | Respiratory resistance (Rrs) - Infancy | Rrs at multiple frequencies (FOT) during infancy | At the age of 3 months (+/- 1 week) | |
Primary | Respiratory resistance (Rrs) - Infancy | Rrs at multiple frequencies (FOT) during infancy | At the age of 6 months (+/- 1 week) | |
Primary | Respiratory resistance (Rrs) - Infancy | Rrs at multiple frequencies (FOT) during infancy | At the age of 12 months (+/- 2 weeks) | |
Primary | Respiratory reactance (Xrs) - Infancy | Xrs at multiple frequencies (FOT) during infancy | At the age of 3 months (+/- 1 week) | |
Primary | Respiratory reactance (Xrs) - Infancy | Xrs at multiple frequencies (FOT) during infancy | At the age of 6 months (+/- 1 week) | |
Primary | Respiratory reactance (Xrs) - Infancy | Xrs at multiple frequencies (FOT) during infancy | At the age of 12 months (+/- 2 weeks) |
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