Bronchopulmonary Dysplasia Clinical Trial
Official title:
Efficacy and Safety of the Intratracheal Administration of Budesonide With Porcine Pulmonary Surfactant in Very Preterm Infants to Prevent Bronchopulmonary Dysplasia: Randomized Clinical Trial (BuS Trial)
This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ≤32 weeks of gestational age (GA).
Bronchopulmonary dysplasia (BPD) is one of the main morbidities associated with extreme prematurity and, despite the improvement of respiratory care in the latest years, overall incidence is not decreasing. Etiology of BPD is multifactorial and local inflammation plays an important role in it, therfore, local anti-inflammatory drugs could be effective in preventing BPD. Recent randomised trials have shown a lower incidence of BPD/death with the use of a combination of budesonide with surfactat compared to surfactant alone, and further clinical trials are currently ongoing. This is a controlled phase IV, randomised, unicenter clinical trial designed to evaluate the effect of intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, in BPD in preterm infants ≤32 weeks of GA. Investigators will compare ecographic and biological markers, as well as respiratory outcomes. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04506619 -
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
|
||
| Completed |
NCT04936477 -
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
|
N/A | |
| Recruiting |
NCT05285345 -
Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
|
||
| Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
| Terminated |
NCT02524249 -
Early Versus Late Caffeine for ELBW Newborns
|
N/A | |
| Completed |
NCT02249143 -
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
|
N/A | |
| Active, not recruiting |
NCT01632475 -
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
|
||
| Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
| Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
| Completed |
NCT00419588 -
Growth of Airways and Lung Tissues in Premature and Healthy Infants
|
||
| Completed |
NCT00208039 -
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
|
N/A | |
| Completed |
NCT00319956 -
Trial II of Lung Protection With Azithromycin in the Preterm Infant
|
Phase 2 | |
| Completed |
NCT00006401 -
Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
|
Phase 3 | |
| Terminated |
NCT05030012 -
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
|
N/A | |
| Completed |
NCT00006058 -
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
|
N/A | |
| Completed |
NCT00005376 -
Premature Birth and Its Sequelae in Women
|
N/A | |
| Completed |
NCT00011362 -
Dexamethasone Therapy in VLBW Infants at Risk of CLD
|
Phase 3 | |
| Completed |
NCT00004805 -
Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death
|
N/A | |
| Completed |
NCT05152316 -
The Baby Lung Study
|
||
| Recruiting |
NCT04821453 -
NAVA vs. CMV Crossover in Severe BPD
|
N/A |