The primary outcome was the need for surfactant replacement therapy or the failure of NIV and need for intubation during the first 72 hours of admission.
Surfactant replacement therapy was done in 34 neonates (55.7%): 15 (44.1%) in the NIPPV group and 19 (55.8%) in the NCPAP group, OR = 1.58 (95% CI: 0.57-4.37, p = 0.370).
This was due to either congenital anomalies, another respiratory disease other than RDS, asphyxia, extubated after one hour of INSURE method, or needed surfactant replacement therapy
after 48 hours birth.
Given the devastating effects of ARDS both in terms of mortality and disease-related complications, inclusion into this program is an opportunity to collaborate closely with the FDA in defining the scope of the development program and endpoints to capture the essence of surfactant replacement therapy for these patients," said Robert J.
Discovery's Surfactant Replacement Therapy is also in a Phase 2 clinical trial for Acute Respiratory Distress Syndrome in adults, a Phase 3 and a Phase 2 clinical trial for Meconium Aspiration Syndrome in full-term infants, and a Phase 1b clinical trial for asthma.
The appearance of the chest x-ray varies depending on the severity and progression of the disease, the ventilatory support applied, the use of surfactant replacement therapy and other possible complications of prematurity.
Surfactant replacement therapy is the primary focus in treating infants with HMD.
While KL4 surfactant is not a traditional antiviral drug, its properties as an exogenous surfactant replacement therapy
to maintain alveolar patency, and to supplement inactivated surfactant in severely inflamed lungs, and its immune-modulatory properties supports the goals of developing therapeutic interventions with broad activity that target host factors involved in reducing lung injury and immunopathology.