Bronchopulmonary Dysplasia Clinical Trial
— REACTOfficial title:
Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants
| NCT number | NCT05986032 |
| Other study ID # | REACT |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 15, 2023 |
| Est. completion date | September 24, 2024 |
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | September 24, 2024 |
| Est. primary completion date | September 3, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Days to 9 Days |
| Eligibility | Inclusion Criteria: - born before 32 weeks post-menstrual age Exclusion Criteria: - congenital abnormalities - Inherited disorders of metabolism |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna | Wien |
| Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Fondazione IRCCS San Gerardo dei Tintori | Monza | Monza E Brianza |
| Netherlands | Amsterdam UMC | Amsterdam | |
| Sweden | Uppsala University Children's Hospital | Uppsala | |
| Switzerland | Universitäts-Kinderspital beider Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione IRCCS San Gerardo dei Tintori | Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Medical University of Vienna, University Children's Hospital Basel, Uppsala University Hospital |
Austria, Italy, Netherlands, Sweden, Switzerland,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | Fraction of inspired oxygen | 7 days of life | ||
| Primary | 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 | |
| Secondary | 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 |
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