An observational study in Bronchopulmonary Dysplasia, sponsored by Fondazione IRCCS San Gerardo dei Tintori. Recruiting at 6 sites in 5 countries. Open to participants aged 5 Days to 9 Days. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Fondazione IRCCS San Gerardo dei Tintori · Observational
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's planned enrollment of 150 is close to the median of 137 across 92 observational studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Fondazione IRCCS San Gerardo dei Tintori is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infants will be recruited from those admitted to tertiary-level neonatal intensive care units.
Exclusion Criteria:
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
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
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
Time frame: Xrs will be measured at 7 days of life
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O
Xrs will be expressed in cmH2O\*S/L
Time frame: Xrs will be measured at 7 days of life
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
Time frame: 7 postnatal days
Fraction of inspired oxygen
Time frame: 7 days of life
Plan to share: No
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Fondazione IRCCS San Gerardo dei Tintori