2005 OPEN FORUM Abstracts
Comparative DOSING TOLERANCE and Clinical response Between LUCINACTANT (Surfaxin®) AND PORACTANT (CUROSURF®) IN VERY LOW BIRTHWEIGHT INFANTS WITH RESPIRATORY DISTRESS SYNDROME
Christina Joseph, RRT-NPS, Chris Henderson, RCP, Discovery Labs, Graham Bernstein, MD Sharp Mary Birch Hospital for Women, Pulmonary Services, San Diego, CA.
Background: In 2002,Sharp Mary Birch Hospital for Women NICU participated in a masked, multicenter, randomized, controlled, non-inferiority trial comparing the safety and effectiveness of Surfaxin® (lucinactant) a new generation, protein-containing synthetic surfactant with porcine-derived Curosurf® (poractant alpha), in the prevention and treatment of Respiratory Distress Syndrome (RDS) in premature neonates of 24 to < 29 weeks estimated gestational age ( 600-1250 g. birth weight). Our center enrolled 29 of the 252 (11.5%) patients in the trial. Initial treatment was administered within the first 30 minutes of life by an unmasked Respiratory Care Practitioner (RCP) at a dose of either Surfaxin at 175mg/kg birth weight (5.8 ml/kg using a 30mg/ml concentration of Surfaxin) or Curosurf 175mg/kg birth weight (2.02 ml/kg using an 80 mg/ml concentration of Curosurf). From 6-48 hours after birth, neonates were retreated for FIO2 > .30 up to 2 doses of either Surfaxin (175 mg/kg) or Curosurf (100mg/kg per label), at least 6 hours apart. The results from this study have recently been published (Sinha S, et al. Pediatrics, 2005;115:130).
Method: Since the volumes of the comparators are different, we investigated dosing tolerance during surfactant administration, and the clinical response following administration of the two study drugs. We looked at the occurrence of significant oxygen desaturation (< 85%) and bradycardia (< 100 BPM) up to 2 hours post drug administration. All doses were administered with positive pressure ventilation.
|Drug||Total neonates||# of Doses||> 85% SaO2||< 85% SaO2||FIO2 at 2 hours Mean (STD)||FIO2 at 24 hours Mean (STD)||Bradycardia < 100 BPM|
|Curosurf||15||20||17||3||0.303 (0.207)||0.249 (0.058)||0|
|Surfaxin||14||21||17||4||0.285 (0.077)||0.298 (0.124)||1|
Conclusion: Our clinical findings demonstrated that there was essentially no difference in dosing tolerance or patient response between the two surfactants despite differences in dosing volume .