Clinical studies & white papersClick on the image or title to download each PDF. Please note that due to licensing arrangements with publishers, some downloads are being provided directly from the publisher’s website.
Infants with RDS may vary markedly in the severity of respiratory disease maturity and presence of other complications, which makes it necessary to individualize patient care. Infants receiving CUROSURF should get frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified in response to respiratory changes, because the administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance.
Verder H, Albertsen P, Ebbesen F, et al. Pediatrics. 1999;103:1-6. This was a multicenter, randomized controlled trial and was one of the first to demonstrate the efficacy of CUROSURF when used in conjunction with nCPAP and the INSURE strategy.
Dani C, Bertini G, Pezzati M, Cecchi A, Caviglioli C, Rubaltelli FF. Pediatrics. 2004;113:e560-e563. This prospective, randomized clinical trial further explores the efficacy of CUROSURF with the INSURE strategy.
Dargaville PA, Aiyappan A, De Paoli AG, et al. Neonatology. 2013;104(1):8-14. This retrospective analysis of prospectively collected data led to the conclusion that although there was no perfect indicator of nCPAP failure, it was predicted by high FiO2 (above 0.30) in the first hours of life. This study may be relevant as clinicians consider which patients are candidates for selective surfactant with INSURE.
Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K; and The North American Study Group. Am J Perinatol. 2004;21:109-119. This study found that the higher 200 mg/kg dose of CUROSURF resulted in faster onset of action and decreased FiO2 requirements compared to a 100 mg/kg dose of Survanta.*
Cogo PE, Facco M, Simonato M, et al. Pediatrics. 2009;124(5):e950-e957. This pharmacokinetic study using CUROSURF with a small amount of radiolabeled dipalmitoylphosphatidylcholine (DPPC) added found that compared with a 100 mg/kg dose of Survanta, the 200 mg/kg dose of CUROSURF demonstrated a longer DSPC half-life.*
Malloy CA, Nicoski P, Muraskas JK. Acta Paediatr. 2005;94:779-784. This prospective, randomized clinical trial found that infants who received CUROSURF had a lower FiO2 requirement in the first 48 hours after surfactant therapy compared to infants who received beractant.*
Gerdes JS, Seiberlich W, Sivieri EM, et al. J Pediatr Pharmacol Ther. 2006;11:92-100. This study compared administration characteristics including administration time, patient recovery time, reflux and bradycardia.Administration traits or end points (eg, faster reduction in FiO2, reflux or bradycardia rates, or oxygen desaturation) have not been proven to impact key clinical outcomes such as mortality or BPD due to RDS.
This white paper examines clinical evidence and practice considerations for implementing an early rescue strategy within a hospital.
CUROSURF® (poractant alfa) is intended for intratracheal use only. The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes.
CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants.
Transient adverse reactions associated with administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.
Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported with CUROSURF. The rates of common complications of prematurity observed in a multicenter single-dose study that enrolled infants 700–2000 g birth weight with RDS requiring mechanical ventilation and FiO2 ≥ 0.60 are as follows for CUROSURF 2.5 mL/kg (200 mg/kg) (n=78) and control (n=66; no surfactant) respectively: acquired pneumonia (17% vs. 21%), acquired septicemia (14% vs. 18%), bronchopulmonary dysplasia (18% vs. 22%), intracranial hemorrhage (51% vs. 64%), patent ductus arteriosus (60% vs. 48%), pneumothorax (21% vs. 36%) and pulmonary interstitial emphysema (21% vs. 38%).
CUROSURF® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.