Indication for the exougenous surfactant administration to treat neonatal respiratory distress syndrome in the preterm infant: a single-center randomized phase 4 trial based on the comparison of two levels of respiratory severity.

INTERVENTION: Trade Name: CUROSURF ‐ 80 MG/ML SOSPENSIONE PER INSTILLAZIONE ENDOTRACHEOBRONCHIALE 2 FLACONCINI 1.5 ML Product Name: CUROSURF Product Code: [10122‐510] Pharmaceutical Form: Endotracheopulmonary instillation, suspension INN or Proposed INN: frazione fosfolipidica da polmone suino CAS Number: 129069‐19‐8 Current Sponsor code: CS‐1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 80‐ CONDITION: Neonatal respiratory distress syndrome (RDS) ; MedDRA version: 21.1 Level: LLT Classification code 10038690 Term: Respiratory distress syndrome (neonatal) System Organ Class: 100000004855 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: To evaluate the superior effectiveness of the respiratory severity level "CURO25" (FiO2>25%) compared to the respiratory severity level CURO35 (FiO2>35% ‐ actual clinical practice in the study center) as indication for the exogenous surfactant administration in preterm infants with respiratory distress syndrome (RDS). Primary end point(s): Respiratory function defined as oxygen saturation/FiO2 ratio (SFR). Secondary Objective: To evaluate the effects of two respiratory severity levels (CURO25 vs CURO35) as indications for the exogenous surfactant administration in preterm infants with respiratory distress syndrome (RDS) in terms of the incidence of neonatal complications, duration of in‐hospital therapy and short‐medium respiratory outcomes. Timepoint(s) of evaluation of this end point: At day 3 of life. SECONDARY OUTCOME: Secondary end point(s): Duration of the oxygen therapy (days); Duration of the mechanical ventilation (days).; Late respiratory function defined as oxygen saturation/FiO2 ratio (SFR).; Silvermann score as secondary respiratory severity index.; Lung ultrasound score (LUS score) as secondary respiratory severity index.; Oxygenation index as an indicator of the intensity of ventilator support.; In‐hospital death.; The incidence of neonatal complications: intraventricular hemorrhage (grade 3 and 4), periventricular leukomalacia, retinopathy of prematurity and bronchopulmonary dysplasia.; Duration of non‐invasive positive pressure ventilation (CPAP ‐ days).; Number of patients who received mechanical ventilation. Timepoint(s) of evaluation of this end point: From the admission to 36 weeks of postmenstrual age or at the discharge if it occurs first.; From the admission to 36 weeks of postmenstrual age or at the discharge if it occurs first..; At day 7 and 28 of life, at 36 weeks of postmenstrual age or at the discharge if it occurs first, and at 1 year of corrected age.; At day 3, 7 and 28 of life and at 36 weeks of postmenstrual age or at the discharge if it occurs first.; At day 3, 7 and 28 of life and at 36 weeks of postmenstrual age or at the discharge if it occurs first.; At day 3, 7 and 28 of life and at 36 weeks of postmenstrual age or at the discharge if it occurs first.; From birth to discharge from the neonatal intensive care unit.; From birth to 36 weeks of postmenstrual age or at the discharge if it occurs first.; From the admission INCLUSION CRITERIA: ‐ gestational age between 24 and 32 weeks postmenstrual age; ‐ diagnosis of neonatal respiratory distress (RDS); ‐ need of invasive/non‐invasive ventilatory support; ‐ written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range