SEE EARLY signs of CPAP failure in RDS, START EARLY rescue

Early rescue (<2 hours after birth) may improve outcomes in preterm infants with RDS compared with delayed rescue (>2 hours after birth)1

Assess criteria

Early identification of CPAP failure should prompt consideration of early surfactant treatment2

Act early

Early rescue has been shown to improve neonatal outcomes3

The decision for early rescue with surfactant is multifactorial4,5

Multifactorial determinants of need for early rescue Multifactorial determinants of need for early rescue

Act early to stabilize preterm infants

The Golden Hour Initiative describes the first few hours after birth, during which the focus is on initial stabilization and continued monitoring of the premature infant to improve outcomes. Efficient, evidence-based care during this time includes thermoregulatory aid, respiratory support, cardiovascular stability, and fluid management6,7

Early rescue in infants with RDS fits within this Golden Hour Initiative, both in the timing, occurring <2 hours after birth, and in the decision to treat RDS8

93% of extremely preterm infants (22-28 weeks GA) developed RDS9

For premature infants, recognizing the earliest signs and symptoms of RDS is important. Respiratory support within the first few hours of birth may include CPAP and early rescue8,10

See signs of CPAP failure and avoid prolonging CPAP in nonresponders

Following stabilization, assess the infant for signs of CPAP failure—the need for mechanical ventilation within 72 hours after birth11,12

In a retrospective analysis, the median age at CPAP failure was
5.6 hours2

5.6 hours

Base the decision for early rescue on a multifactorial risk assessment

Both infant and maternal factors can contribute to an increased risk for RDS and CPAP failure4,5,13,14

Infant Factors4,13,15

  • <32 weeks gestational age
  • Cesarean delivery
  • Hypothermia
  • Low birth weight
  • APGAR score ≤3 at 1 minute | Silverman score >2 at 2 hours
  • High oxygen requirements (eg, FiO2)
  • Clinical subjective respiratory signs (eg, labored breathing,
    nasal flaring)

Maternal Factors5,14,16-19

  • No antenatal steroid use
  • Premature rupture of membranes
  • Comorbidities (eg, hypertension, overweight/obesity)
  • Nutritional status
  • Smoking
  • Exposure to air pollution

Early identification of CPAP failure is key to successful early rescue.13,20 An individualized approach that considers all aspects of the infant’s condition should be used4,13,20

 
PREDICTING CPAP FAILURE
  

Multiple studies have shown that FiO2 is the strongest available predictor of CPAP failure and can predict >70% of CPAP failures in the first 2 hours after birth

Multiple studies report that a threshold of around 0.3 may be used to identify infants at risk for CPAP failure and a point at which to introduce early rescue surfactant therapy13,20,22*

Studies of the predictive value of a FiO2 threshold of 0.3 and 0.29

These results may be considered as support for optimizing the timing of surfactant administration using an FiO2 threshold around 0.3

View study designs *FiO2 threshold is a precautionary alert and an indicator of the potential need for surfactant administration to enhance the chance for CPAP success but not as an infallible predictor of CPAP failure.

Guidelines recommend early surfactant administration on the basis of clinical recognition of the predictive value of a lower FiO2 threshold

2014 AAP Committee on Fetus and Newborn recommends early administration of surfactant followed by rapid extubation if additional ventilation will likely be needed8,10

  • Use CPAP immediately after birth with selective surfactant administration over routine intubation with prophylactic or early surfactant administration
  • Early rescue within 1 to 2 hours after birth
  • If it is likely that respiratory support with a ventilator will be needed, early administration of surfactant followed by rapid extubation is preferable to prolonged ventilation

Latest 2019 update to European Consensus Guidelines revised their recommendation on the optimal threshold, from 0.4 to 0.3, to administer surfactant to all spontaneously breathing infants at risk for CPAP failure16‡

  • Observational studies have confirmed that FiO2 >0.30 in the first hours after birth in babies on CPAP is a reasonably good test for predicting subsequent CPAP failure. Therefore, it is recommended that the threshold of FiO2 >0.30 is used for all infants with a clinical diagnosis of RDS
  • For infants <28 weeks GA, initiate with 30% oxygen and 21% to 30% oxygen for 28 to 31 weeks GA; titrate up or down as needed according to SpO2 targets
FiO2 thresholds from the 2013 EU guidelines and the 2019 EU guidelines ‡The European Consensus Guidelines on the management of RDS reflect the clinical practice standards and medications approved for use in EU hospitals; as such, certain recommendations may not be relevant to US clinical practice. US and EU patient populations and clinical practice standards are widely accepted to be distinct; therefore, there may be significant limitations to the extrapolation of certain data from EU studies to the US patient population. European Consensus Guidelines on RDS management have been updated to reflect earlier surfactant administration based on lower FiO2 levels (0.3) to help optimize the timing of surfactant treatment

AAP=American Association of Pediatrics; BPD=bronchopulmonary dysplasia; CPAP=continuous positive airway pressure; EU=European Union; FiO2=fraction of inspired oxygen; GA=gestational age; HOL=hours of life; NICU=neonatal intensive care unit; RDS=respiratory distress syndrome; ROC=receiver operating characteristic; SpO2=oxygen saturation.

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.

References: 1. Bahadue FL, Soll R. Cochrane Database Syst Rev. 2012;11(11):CD001456. 2. Fuchs H, Lindner W, Leiprecht A, Mendler MR, Hummler HD. Arch Dis Child Fetal Neonatal Ed. 2011;96(5):F343-F347. 3. Stevens TP, Harrington EW, Blennow M, Soll RF. Cochrane Database Syst Rev. 2007;2007(4):CD003063. 4. Nanda D, Nangia S, Thukral A, Yadav CP. Eur J Pediatr. 2020;179(4):603-610. 5. Tian T, Wang L, Ye R, Liu J, Ren A. Pregnancy Hypertens. 2020;19:131-137. 6. Fathi O, Bapat R, Shepherd EG, et al. In: Chubarova AI, ed. Neonatal Medicine. 2019. Accessed September 15, 2022. https://www.intechopen.com/chapters/64996 7. Lagoski M, Hamvas A. Surfactant therapy. In: Jain L, Suresh GK. eds. Clinical Guidelines in Neonatology. McGraw-Hill Education; 2019. 8. Polin RA, Carlo WA; Committee on Fetus and Newborn; American Academy of Pediatrics. Pediatrics. 2014;133:156-163. 9. Stoll BJ, Hansen NI, Bell EF, et al. Pediatrics. 2010;126(3):443-456. 10. Committee on Fetus and Newborn, American Academy of Pediatrics. Pediatrics. 2014;133(1):171-174. 11. Annibale DJ, Bissinger RL. Adv Neonatal Care. 2010;10(5):221-222. 12. Dargaville, PA, Gerber A, Johansson S, et al. Pediatrics. 2016;138(1):e20153985. 13. Dargaville PA, Aiyappan A, De Paoli AG, et al. Neonatology. 2013;104(1):8-14. 14. Terfa ZG, Nantanda R, Lesosky M, et al. BMJ Open. 2022;12:e050729. 15. Schwartz CI, Zieve D. MedLinePlus: Medical Encyclopedia. April 14, 2021. Accessed July 26, 2022. https://medlineplus.gov/ency/article/001563.htm 16. Sweet DG, Carnielli V, Greisen G, et al. Neonatology. 2019;115(4):432-450. 17. Gyamfi- Bannerman C, Thom EA, Blackwell SC, et al. N Engl J Med. 2016;374(14):1311-1320. 18. Pillai MS, Sankar MJ, Mani K, et al. J Trop Pediatr. 2011;57(4):274-279. 19. Ovesen P, Rasmussen S, Kesmodel U. Obstet Gynecol. 2011;118(2 Pt 1):305-312. 20. Kakkilaya V, Wagner S, Mangona KLM, et al. J Perinatol. 2019;39(8):1081-1088. 21. Rojas MA, Lozano JM, Rojas MX, et al. Pediatrics. 2009;123:137-142. 22. Gulczyńska E, Szczapa T, Hozejowski R, et al. Neonatology. 2019;116(2):171-178.