HEALTHCARE PROFESSIONAL RESOURCES

This resource section is designed to provide you with helpful information about respiratory distress syndrome in premature infants and CUROSURF. Find clinical resources and videos all in one convenient place.

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NICU resources

CUROSURF User Guide

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CUROSURF Dosing Card

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CUROSURF Dosing Chart

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Educational videos

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CUROSURF User Guide Video

The User Guide Video details the safety and efficacy data behind CUROSURF, and walks through the storage, dosing, and administration procedures found in our Full Prescribing Information. This video may be particularly helpful during a Skills Day or for educating new staff.

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INSURE: An Option for Treating Infants Following NIV Failure

This short video provides an overview of some of the research behind the INSURE strategy and a detailed step-by-step video guide of how to administer CUROSURF.

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Pharmacy resources

Evaluating Surfactants for Formulary

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Since surfactants cannot be considered pharmaceutical equivalents, it is important to evaluate the drug class comprehensively. This white paper discusses some factors to consider and which stakeholders to consult as you evaluate the surfactant class.

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We worked with Carla Christensen, PharmD, to develop this video presentation of some of the considerations that she recommends incorporating into a surfactant Medication Use Evaluation.

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Video lectures

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The INSURE Strategy: Selective Surfactant Following nCPAP Failure

In this lecture, Dana Evans, MHA, RRT-NPS, highlights some of the latest research into less invasive ventilation for babies with respiratory distress syndrome, and how CUROSURF may be a good fit for your protocols.

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A Comparison of Approved Natural Surfactants

In this “grand rounds style” lecture, Lance Parton, MD, FAAP, presents some of the similarities and differences between the currently available natural exogenous surfactants.

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Evaluating Surfactants: A Pharmacy Perspective

Presented by Jennifer Gorrell, PharmD, this “grand rounds style” presentation includes some information about surfactants that might be helpful to consider from a pharmacy perspective.

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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.

It is important to note that the INSURE strategy may not be appropriate for all infants. Infants with RDS may vary markedly in the severity of respiratory disease, maturity, and presence of other complications, and thus it is necessary to individualize patient care.

Clinical studies

Click 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.

Less invasive ventilation

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.

Nasal continuous positive airway pressure and early surfactant therapy for respiratory distress syndrome in newborns of less than 30 weeks’ gestation
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.
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Physiological end points (e.g., improved oxygenation and lower respiratory index) have not been proven to impact key clinical outcomes such as mortality due to respiratory distress syndrome. Clinical studies have not established that fewer doses result in superior safety or efficacy based on clinically relevant endpoints. As you consider this trial, please keep in mind that every patient varies in maturity, the severity of RDS, and other factors; thus extubation should be performed when the infant is stable and at the discretion of the clinician. Infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support and be modified to respond to respiratory changes, because the administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Please note that due to licensing arrangements with publishers some downloads are being provided directly from the publisher’s website.

Early extubation and nasal continuous positive airway pressure after surfactant treatment for respiratory distress syndrome among preterm infants <30 weeks’ gestation
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.
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Physiological end points (e.g., faster reduction in FiO2) have not been proven to impact key clinical outcomes such as mortality due to respiratory distress syndrome. Clinical studies have not established that fewer doses result in superior safety or efficacy based on clinically relevant endpoints. As you consider this trial, please keep in mind that every patient varies in maturity, the severity of RDS, and other factors; thus extubation should be performed when the infant is stable and at the discretion of the clinician. Infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support and be modified to respond to respiratory changes, because the administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Please note that due to licensing arrangements with publishers some downloads are being provided directly from the publisher’s website.

Continuous positive airway pressure failure in preterm infants: incidence, predictors and consequences
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.
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Comparative trials

A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants
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.*
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Dosing of porcine surfactant: effect on kinetics and gas exchange in respiratory distress syndrome
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.*
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A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome
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.*
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An open-label comparison of calfactant and poractant alfa administration traits and impact on neonatal intensive care unit resources
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.
VIEW STUDY

Administration traits or endpoints (e.g., faster reduction in FiO2, reflux and bradycardia rates or oxygen desaturation) have not been proven to impact key clinical outcomes such as mortality or BPD due to respiratory distress syndrome (RDS). Clinical studies have not established that lower surfactant dose volumes result in superior safety or efficacy based on clinically relevant endpoints and there have been no prospective, randomized clinical trials comparing CUROSURF to calfactant intratracheal suspension. As you consider this trial, please keep in mind that every patient varies in maturity, the severity of RDS, and other factors; thus extubation should be performed when the infant is stable and at the discretion of the clinician. Infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support and be modified to respond to respiratory changes, because the administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Please note that due to licensing arrangements with publishers some downloads are being provided directly from the publisher’s website.

*Physiological and pharmacokinetic end points (eg, faster reduction in FiO2, lower respiratory support, and longer DSPC half-life) have not been proven to impact key clinical outcomes such as mortality due to respiratory distress syndrome (RDS).


It is important to note that the INSURE strategy may not be appropriate for all infants. Infants with RDS may vary markedly in the severity of respiratory disease, maturity, and presence of other complications, and thus it is necessary to individualize patient care.

IMPORTANT SAFETY INFORMATION

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%).

INDICATION

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.

Please see Full Prescribing Information.