Intended for healthcare professionals in the UK and Ireland. Click here for Adverse Event Reporting.

Prescribing Information

Prescribing Information

 
 
 
 

CUROSURF: helping you transform
RDS outcomes1

 

National guidelines emphasise the importance of achieving optimal outcomes in neonatal critical care to reduce preterm mortality rates, and early surfactant therapy, endorsed by NHS initiatives and NICE guidelines, plays a crucial role in these efforts.2–8

 

 

Studies suggest that infants experiencing CPAP failure are at a higher risk of adverse outcomes, including pneumothorax, BPD, and intraventricular haemorrhage, compared with those who are successfully managed with CPAP alone. 9,10

 

CUROSURF may improve these outcomes as studies have shown that administering surfactant at the first signs of CPAP failure can reduce the need for mechanical ventilation and consequently lower the risk of developing BPD, which is a prevalent morbidity with significant long-term implications for preterm infants.11–13

 
 

Parents are often concerned about the potential side effects of medications and should be actively involved in all treatment discussions; therefore, a plan for administering CUROSURF should be discussed with parents as soon as possible after NICU admission.14

 

 

It is crucial to provide sufficient information about the risks and benefits to ensure they can make an informed decision, in line with the BAPM shared decision-making framework.14,15

 
 

Several studies have identified FiO2 as the most reliable predictor of CPAP failure — Dargaville et al. found that an FiO2 greater than 0.30 predicts over 70% of CPAP failures within the first two hours after birth, while Gulczynska et al. showed that an FiO2 of 0.29 is a significant indicator of CPAP failure.16–18

 
 

Fast facts

  • Infants who fail CPAP are at a higher risk of adverse outcomes compared with those who are successfully managed on CPAP9,10
  • Preterm infants ≤25-28 weeks GA are more likely to fail initial CPAP and require respiratory support and oxygen therapy than infants ≥29-32 weeks GA16
  • A significant portion of preterm infants managed on CPAP from the outset go on to require intubation in the first days of life16
 

Guideline recommendations

  • European Consensus Guidelines gives their highest recommendation for the administration of surfactant early in the course of RDS (A1)19
  • Early surfactant therapy endorsed by both NHS initiatives and NICE guidelines2–8
 

FiO2 is the strongest predictor of CPAP failure.16–18

 

Ensuring the success of CPAP therapy is critical in neonatal care, as it significantly impacts the health and development of premature infants by reducing the incidence of adverse outcomes compared with infants who fail CPAP.9,10

 

Several studies have identified FiO2 as the most reliable predictor of CPAP failure — Dargaville et al. found that an FiO2 greater than 0.30 predicts over 70% of CPAP failures within the first two hours after birth, while Gulczynska et al. showed that an FiO2 of 0.29 is a significant indicator of CPAP failure.16–18

 

European Consensus Guidelines suggests a protocol for the early administration of surfactant to infants with RDS of an FiO2 >0.30 on CPAP pressure ≥6 cm H2O or if lung ultrasound suggests a surfactant need.19

 

ROC curve for prognosing CPAP failure according the the highest FiO2 level in the second hour of life. The cutoff point corresponds to the highest specificity and sensitivity values.18

 

Adapted from Gulczynska E, et al. Neonatology. 2019

 

CPAP failure can also result in a 20-fold higher risk of death compared with CPAP success18

 

Adapted from Gulczynska E et al. Neonatology 2019.18

 

Increasing CPAP success rates reduces the need for mechanical ventilation, which, in turn, may reduce the risk of developing BPD.11-13 Reducing neonatal mortality is a key focus of the NHS long-term plan.3

 

Neonatology Education,
Skills and Training

 
 

Chiesi is committed to advancing medical education with innovative and comprehensive training programmes, aiming to equip HCPs with the essential knowledge, skills, and expertise to thrive in the dynamic field of neonatology.   

 
 

In investing in your professional growth and staying at the forefront of a rapidly evolving medical landscape! 

 
 

Abbreviations

 

AUC, Area under the curve; BPD, bronchopulmonary dysplasia; CPAP, continuous positive airway pressure; ECG, European Consensus Guidelines; FiO2, fraction of inspired oxygen; NICE, National Institute for Health and Care Excellence; RDS, respiratory distress syndrome. 

 
 

References

  1. CUROSURF SmPC. Available at https://www.medicines.org.uk/emc/product/6450/smpc. Accessed September 2024.
  2. NICE guidelines [NG124]. Specialist neonatal respiratory care for babies born preterm. Available at https://www.nice.org.uk/guidance/ng124. Accessed September 2024.
  3. NHS long-term plan (2019). Available at https://www.longtermplan.nhs.uk/wp-content/uploads/2019/08/nhs-long-term-plan-version-1.2.pdf. Accessed September 2024.
  4. NHS England. Implementing the Recommendations of the Neonatal Critical Care Transformation Review (2019). Available at https://www.england.nhs.uk/wp-content/uploads/2019/12/Implementing-the-Recommendations-of-the-Neonatal-Critical-Care-Transformation-Review-FINAL.pdf. Accessed September 2024.
  5. NHS England Maternity Transformation Programme. Available at https://www.england.nhs.uk/mat-transformation/. Accessed September 2024.
  6. NHS England. Better Births (2016). Available at https://www.england.nhs.uk/wp-content/uploads/2016/02/national-maternity-review-report.pdf. Accessed September 2024.
  7. NHS Scotland. The Best Start. Available at https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2017/01/best-start-five-year-forward-plan-maternity-neonatal-care-scotland/documents/00513175-pdf/00513175-pdf/govscot%3Adocument/00513175.pdf. Accessed September 2024.
  8. NHS England. Three year delivery plan for maternity and neonatal services. Available at https://www.england.nhs.uk/wp-content/uploads/2023/03/B1915-three-year-delivery-plan-for-maternity-and-neonatal-services-march-2023.pdf. Accessed September 2024.
  9. Kwok TC, et al. Respiratory management and outcomes in high-risk preterm infants with development of a population outcomes dashboard. Thorax 2023;78:1215–1222.
  10. Subramaniam P, et al. Prophylactic or very early initiation of continuous positive airway pressure (CPAP) for preterm infants. Cochrane Database of Systematic Reviews 2021;10:CD001243: DOI: 10.1002/14651858.CD001243.pub4.
  11. Fuchs H, et al. Predictors of early nasal CPAP failure and effects of various intubation criteria on the rate of mechanical ventilation in preterm infants of <29 weeks gestational age. Arch Dis Child Fetal Neonatal Ed. 2011;96(5):F343–7.
  12. De Jaegere AP, et al. Early prediction of nasal continuous positive airway pressure failure in preterm infants less than 30 weeks gestation. Acta Paediatr. 2012;101(4):374–9.
  13. Rocha G, et al. Failure of early nasal continuous positive airway pressure in preterm infants of 26 to 30 weeks gestation. J Perinatol. 2013;33(4):297–301.
  14. Reynolds P, et al. Less-Invasive Surfactant Administration for Neonatal Respiratory Distress Syndrome: A Consensus Guideline. Neonatology. 2021;118(5):586–592.
  15. BAPM. Enhanced shared decision making in neonatal medicine — a framework for practice (2019). Available at https://www.bapm.org/resources/158-enhancing-shared-decision-making-in-neonatal-care. Accessed September 2024.
  16. Dargaville PA, et al. Continuous positive airway pressure failure in preterm infants: incidence, predictors and consequences Neonatology. 2013;104(1):8–14.
  17. Kakkilaya V, et al. Early predictors of continuous positive airway pressure failure in preterm neonates J Perinatol. 2019;39(8):1081–1088.
  18. Gulczyńska E, et al. Fraction of Inspired Oxygen as a Predictor of CPAP Failure in Preterm Infants with Respiratory Distress Syndrome: A Prospective Multicenter Study. Neonatology. 2019;116(2):171–178.
  19. Sweet DG, et al. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3–23.
 
 

IE-CUR-2400042 | December 2024

 

Adverse event reporting

For the UK: Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.

For Ireland: Adverse events should be reported to HPRA Pharmacovigilance – www.hpra.ie. Adverse events should also be reported to Chiesi Limited on 1800 817459 (IE) or PV.UK@Chiesi.com.