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| Name | Class |
|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
| University Children's Hospital Basel | OTHER |
| Uppsala University Hospital | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| bronchopulmonary dysplasia | Group of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Oscillometry | Diagnostic Test | Measurement of respiratory system reactance by respiratory oscillometry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure | Xrs will be expressed in z-score using reference equation for very preterm infants | Xrs will be measured at 7 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O | Xrs will be expressed in cmH2O*S/L | Xrs will be measured at 7 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory support mode | 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 | 7 postnatal days |
| Fraction of inspired oxygen |
Inclusion Criteria:
Exclusion Criteria:
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Infants will be recruited from those admitted to tertiary-level neonatal intensive care units.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camilla Rigotti, PhD | Contact | +39039233 | 9173 | dr.camilla.rigotti@gmail.com |
| Emanuela Zannin, PhD | Contact | +393389323437 | emanuela.zannin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Camilla Rigotti, PhD | Fondazione IRCCS San Gerardo dei Tintori | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Enrolling by invitation | Vienna | State of Vienna | 1090 | Austria | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31108499 | Background | 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. | |
| 30127523 | Background | 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. |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Medical University of Vienna |
| OTHER |
| Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) | OTHER |
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| 7 days of life |
| Fondazione IRCCS San Gerardo dei Tintori |
| Recruiting |
| Monza |
| Monza E Brianza |
| 20900 |
| Italy |
|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Enrolling by invitation | Milan | 20122 | Italy |
| Amsterdam UMC | Enrolling by invitation | Amsterdam | Netherlands |
| Uppsala University Children's Hospital | Enrolling by invitation | Uppsala | S-751 85 | Sweden |
| Universitäts-Kinderspital beider Basel | Enrolling by invitation | Basel | 4056 | Switzerland |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |