Bronchopulmonary dysplasia (BPD) remains one of the most common complications in extremely preterm infants despite advances in neonatal intensive care. Early identification of infants at high risk for BPD could facilitate individualized treatment strategies and improve long-term respiratory outcomes. However, current prediction models rely primarily on conventional clinical variables and have limited predictive accuracy.
This prospective observational study aims to evaluate the predictive value of novel physiological, imaging, and biomarker-based indicators for the development of BPD in infants born before 26 weeks of gestation. Participants admitted to the neonatal intensive care units of the Medical University of Vienna will undergo non-invasive assessments during routine clinical care. These include respiratory function monitoring during neonatal transition, lung ultrasound, diaphragmatic ultrasound, targeted neonatal echocardiography, forced oscillation technique, neurally adjusted ventilatory assist-derived diaphragmatic electrical activity, electrical impedance tomography, and proteomic analyses of plasma and tracheal aspirate samples.
The association between these novel indicators and respiratory disease severity will be assessed using the Respiratory Severity Score (RSS). Their ability to predict BPD will be evaluated using receiver operating characteristic (ROC) analysis and uni- and multivariable logistic regression models. Predictive performance will be assessed using the C-statistics.
The primary objectives are to determine the correlation between the novel indicators and the RSS and to evaluate their diagnostic accuracy for predicting BPD. Secondary objectives include identifying the combination of indicators that provides the best prediction of BPD, evaluating longitudinal changes in respiratory and cardiovascular parameters during the neonatal period, assessing the effects of respiratory interventions and treatments on these indicators, and investigating associations with survival and major neonatal morbidities.
A total of 140 extremely preterm infants is planned for inclusion in the study. The results are expected to improve early risk stratification and contribute to the development of individualized strategies for preventing and managing BPD.
Preterm infants born at <26 weeks' gestational age, as determined by the best obstetric estimate based on the first day of the last menstrual period and/or first-trimester ultrasonography.
Admitted to the neonatal intensive care unit (NICU) of the Medical University of Vienna immediately after birth.
Written informed consent obtained prospectively from a parent or other legally authorized representative prior to study participation.
Major congenital anomaly or anticipated alternative cause for respiratory failure.
Preterm infants admitted to the neonatal intensive care units of the Medical University of Vienna.
Cohort
Prospective
Not listed
Bronchopulmonary Dysplasia (BPD)
No BPD: no support. BPD grade 1: nasal cannula ≤ 2 L/min. BPD grade 2: nasal cannula \> 2 L/min or noninvasive positive airway pressure. BPD grade 3: invasive mechanical ventilation.
Respiratory Severity Score (RSS)
Daily median Respiratory Severity Score (RSS), calculated as the product of the mean airway pressure (MAP, cmH₂O) and the fraction of inspired oxygen (FiO₂), using all recorded ventilator settings during a 24-hour period.
Peak inspiratory pressure (RFM-PIP)
Peak inspiratory pressure during neonatal transition and resuscitation assessed by the Respiratory Function Monitor (RFM)
Expiratory tidal volume (RFM-VTe)
Expiratory tidal volume during neonatal transition and resuscitation assessed by the Respiratory Function Monitor (RFM)
Composite outcome: Death or Grade 3 BPD
Death: death before 36 weeks' postmenstrual age BPD grade 3: invasive mechanical ventilation at 36 weeks' postmenstrual age
Ventilation parameters
Days of invasive ventilaion Days of non-invasive ventilation (excluding CPAP) Days of CPAP Days of HFNC Days of FiO2-supplement
Major morbidities
necrotizing enterocolitis sepsis intraventricular hemorrhage periventricular leukomalacia retinopathy of prematurity
Neurological outcome
Neurodevelopmental outcomes at two and five years of corrected age were assessed using the Bayley Scales of Infant and Toddler Development during standard follow-up visits.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
