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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
Poractant alfa (Curosurf®): First dose of treatment: 200mg/Kg. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg.
Poractant alfa (Curosurf®) + Budesonide nebulizer solution (Budesonida Aldo-Unión 0.5mg/mL suspensión para inhalación por nebulizador®): First dose: 200mg/Kg of surfactant + 0.25mg/Kg of budesonide. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg of surfactant + 0.25mg/Kg of budesonide.
Lung ultrasound score at 7 days of life.
LUS will be performed with the patients in supine position and slightly lying on the side of the taken view. Each lung will be divided in five areas through longitudinal orientation and images will be taken using the linear probe (VF 13-5MHz).
Time frame: 7 days of life
IL-6 concentration in respiratory secretions at 7 days of life.
Nasopharyngeal aspirate (NPA) will be collected by standard procedure. IL-6 concentration will be determined by Human IL-6 Quantikine ELISA (R\&D Systems Inc., Minneapolis, MN, USA).
Time frame: 7 days of life
Lung ultrasound score at 28 days of life.
LUS will be performed with the patients in supine position and slightly lying on the side of the taken view. Each lung will be divided in five areas through longitudinal orientation and images will be taken using the linear probe (VF 13-5MHz).
Time frame: 28 days of life
IL-6 concentration in respiratory secretions at 28 days of life.
Nasopharyngeal aspirate (NPA) will be collected by standard procedure. IL-6 concentration will be determined by Human IL-6 Quantikine ELISA (R\&D Systems Inc., Minneapolis, MN, USA).
Time frame: 28 days of life
Number of days of oxygen
Number of days on FiO2 \>21% supplied by any respiratory support
Time frame: 7 and 28 days of age, 36 weeks of post-menstrual age.
Number of days of respiratory support
Number of days on each level of respiratory support: * No respiratory support * Nasal cannula at flow rates ≤ 2L/min * Nasal cannula at flow rates \> 2L/min * CPAP/BIPAP * Invasive mechanical ventilation
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Time frame: 7 and 28 days of age, 36 weeks of post-menstrual age.
Mean airway pressure (MAP)
Maximum MAP mesured in cmH2O at 7 and 28 days of age, 36 weeks of postmenstrual age.
Time frame: 7 and 28 days of age, 36 weeks of post-menstrual age.
Incidence of bronchopulmonary dysplasia
BPD will be defined according to the 2001 workshop definition (Jobe AH, Bancalari E. Bronchopulmonary dysplasia. American Journal of Respiratory and Critical Care Medicine. American Lung Association; 2001; pp 1723-9).
Time frame: 36 weeks of post-menstrual age.
Respiratory status and neurodevelopment
Neurodevelopment will be assessed using Bayley-III test.
Time frame: 24 months of age.