In VLBW premature infants who have been intubated and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS)
Conditions
Interventions
Trade Name: Surfaxin
Product Name: Surfaxin (Lucinactant)
Product Code: KL4-Surfactant, DSC-104
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
INN or Proposed INN: Sinapultide
Curr
Sponsors
Discovery Laboratoryies, INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Birthweight 600 to 900 grams,2. Endotracheal intubation and mechanical ventilation with FiO2>0.3.0 on DOL 3,3. Treatment with surfactant on DOL 1 consistent with standard of care, and4. Legally authorized representative agrees to the individual’s participation in the study by signing and datind the 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
Exclusion criteria
Exclusion criteria: 1. infants born to a mother with a prolonged rupture of membrans >/=2 weeks 2. Infant with culture proven sepsis 3 Clinical suspition of high grade IVH as determined by profoundly abnormal neurological exam or head ultrasound consistent with Grade IV IVH 4. congenital heart disease with L-R shunt 5. congenital anomalies inconsistent with life or likely to confound efficacy or safety endpoints 6. Prior use of nitric oxide and 7 prior use of steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Determine the safety and tolerability of Surfaxin administration in the first weeks of life as a therapeutic approach for prevention of BPD in very low birth weight premature infants who had been intubated and received surfactants for the prevention or treatment of RDS. ;Secondary Objective: 2. Determine whether treatment with Surfaxin during the first two weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen). ;Primary end point(s): Safety:· Acute safety and tolerability of administration for up to 5 doses; and· Effects on complications of prematurity.Efficacy:· Proportion of infants remaining on mechanical ventilation or oxygen over time;· Incidence of death or BPD at 28 days and 36 weeks PMA;· AUCday3-28 FiO2 and MAP between treatment groups;· Dynamic pulmonary compliance as assessed by ventilator derived pressure-volume loops pre, 6 and 24 hours post dose (at select sites); and· Surrogate measures of efficacy which include assessment of surface tension lowering properties of tracheal aspirates and concentration of growth factors and inflammatory mediators in tracheal aspirates collected as a part of routine NICU care (at select sites). Specifics regarding collection, handling and assay will follow in a sub-study protocol amendment. | — |
Countries
Hungary
Outcome results
None listed