REACT: Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia
Study Details
Study Description
Brief Summary
The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation. The main question it aims to answer is if the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry measurements at 7 ± 2 postnatal days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| no bronchopulmonary dysplasia Group of patients who do not receive the diagnosis of bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-mentrual age |
Diagnostic Test: Respiratory Oscillometry
Measurement of respiratory system reactance by respiratory oscillometry
|
| bronchopulmonary dysplasia Group of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age. |
Diagnostic Test: Respiratory Oscillometry
Measurement of respiratory system reactance by respiratory oscillometry
|
Outcome Measures
Primary Outcome Measures
- Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure [Xrs will be measured at 7 days of life]
Xrs will be expressed in z-score using reference equation for very preterm infants
Secondary Outcome Measures
- Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O [Xrs will be measured at 7 days of life]
Xrs will be expressed in cmH2O*S/L
Other Outcome Measures
- Respiratory support mode [7 postnatal days]
Respiratory support mode will be coded as 0 = no respiratory support, 1 = nasal high flow therapy, 2 = nasal CPAP or nasal IPPV, 3 = invasive mechanical ventilation
- Fraction of inspired oxygen [7 days of life]
Eligibility Criteria
Criteria
Inclusion Criteria:
- born before 32 weeks post-menstrual age
Exclusion Criteria:
-
congenital abnormalities
-
Inherited disorders of metabolism
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna | Vienna | Wien | Austria | 1090 |
| 2 | Fondazione IRCCS San Gerardo dei Tintori | Monza | Monza E Brianza | Italy | 20900 |
| 3 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | Italy | 20122 | |
| 4 | Amsterdam UMC | Amsterdam | Netherlands | ||
| 5 | Uppsala University Children's Hospital | Uppsala | Sweden | S-751 85 | |
| 6 | Universitäts-Kinderspital beider Basel | Basel | Switzerland | 4056 |
Sponsors and Collaborators
- Fondazione IRCCS San Gerardo dei Tintori
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- University Children's Hospital Basel
- Uppsala University Hospital
- Medical University of Vienna
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Investigators
- Principal Investigator: Camilla Rigotti, PhD, Fondazione IRCCS San Gerardo dei Tintori
Study Documents (Full-Text)
None provided.More Information
Publications
- Veneroni C, Wallstrom L, Sindelar R, Dellaca' RL. Oscillatory respiratory mechanics on the first day of life improves prediction of respiratory outcomes in extremely preterm newborns. Pediatr Res. 2019 Feb;85(3):312-317. doi: 10.1038/s41390-018-0133-6. Epub 2018 Aug 4.
- Zannin E, Neumann RP, Dellaca R, Schulzke SM. Forced oscillation measurements in the first week of life and pulmonary outcome in very preterm infants on noninvasive respiratory support. Pediatr Res. 2019 Sep;86(3):382-388. doi: 10.1038/s41390-019-0432-6. Epub 2019 May 20.
- REACT