Implementing Early Rescue With Exogenous Surfactant

Studies have shown that early rescue—using exogenous surfactant within 2 hours of birth—may improve outcomes in preterm infants with RDS. Determining whether a preterm infant needs early rescue requires a multivariable assessment to make a more nuanced decision. Clinical studies and guidelines detail multiple factors used during a clinician’s decision-making process.^1-8*

*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.

Base the decision for early rescue on a multifactorial assessment

Studies examined multiple infant and maternal factors to determine which characteristics may signal the need for early rescue. The list below reflects the factors from up to 6 different studies that were significant determinants for the need for early rescue.^1-6†‡

^†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.

Fuchs H, et al^1‡

FiO₂
Gestational age
Birth weight

De Jaegere AP, et al^2‡

FiO₂
Gestational age
Birth weight
Gender
CPAP level

Rocha G, et al^3‡

FiO₂
Gender
CPAP duration and pressure
Oxygen >0.30 in delivery room

Dargaville PA, et al⁴

FiO₂
Gestational age
Birth weight
C-section
CPAP level

Kakkilaya V, et al⁵

FiO₂
Birth weight
C-section
Antenatal steroids
Pregnancy-induced hypertension
Blood gases

Gulczyńska E, et al⁶

FiO₂
Gestational age
Birth weight

^‡These studies are not head to head and were conducted outside the US. For more details, please refer to the studies.

See 6 Study Designs

Early identification of CPAP failure is key to successful early rescue with surfactant therapy; an individualized approach that considers all aspects of the infant’s condition should be used.⁶

FiO₂ and CPAP failure^§‖

Three studies show that^4-6:

FiO₂ is the strongest available predictor
FiO₂ can predict more than 70% of CPAP failures in the first 2 hours after birth

Using FiO₂ as one of the predictors of CPAP outcomes may support favorable outcomes, given that CPAP failure has been associated with increased odds of adverse clinical consequences.^1,4-6

Dargaville PA, et al: 0.30 FiO2 threshold

AUC=0.83 for GA 25 to 28 weeks
AUC=0.81 for GA 29 to 32 weeks

Gulczyńska E, et al: 0.29 FiO2 threshold

AUC=0.70

AUC=0.81

An FiO₂ threshold of ≥0.30 may be used to identify infants at risk for CPAP failure and as a clinical reference point to consider introducing early rescue therapy.^4-6

See 3 Study Designs

These results may be considered as support for optimizing the timing of surfactant administration using an FiO₂ threshold around 0.30, as it may improve outcomes for preterm infants with RDS.^4-6,8,9

^‖Data do not reflect the use of a specific surfactant in the treatment of RDS but are conversely indicative of early rescue with CPAP. Other endpoints were analyzed for CPAP failure vs success and reported graphically in the studies, including major morbidity, pneumothorax, mortality, and necrotizing enterocolitis. These were reported in both age cohorts.

The Golden Window Initiative^9-11

The Golden Window Initiative describes the first few hours after birth, during which the focus is on initial stabilization and continued monitoring of the preterm infant to improve outcomes.

Providing efficient, evidence-based care during this time includes thermoregulatory aid, respiratory support, cardiovascular stability, and fluid management.

Early rescue with surfactant therapy in infants with RDS fits within this Golden Window Initiative, both in the timing—occurring <2 hours after birth—and the decision to treat RDS.

Golden Window Initiative — checklist and clock icon

Guidelines recommend early rescue with exogenous surfactant

Guidelines recommend early surfactant administration based on clinical recognition of the predictive value of a lower FiO₂ threshold.^8,9

2014 AAP Committee on the Fetus and Newborn

recommends early administration of surfactant followed by rapid extubation if additional ventilation will likely be needed⁹

Latest 2025 update to European Consensus Guidelines

has maintained its recommendation for using a threshold of FiO₂ ≥0.30 to administer surfactant to preterm infants at risk of CPAP failure and worsening RDS⁸*

Current European Consensus Guidelines on RDS management*

European Consensus Guidelines on RDS management have been updated to reflect earlier surfactant administration based on lower FiO₂ levels (≥0.30) to help optimize the timing of surfactant treatment, which may improve outcomes for preterm infants with RDS.⁸

2025 EU update retains FiO2 threshold of 0.30 or greater

Establishing NICU guidelines using evidence-based practices and multivariable risk assessment can enhance care for preterm infants with RDS.^1,4-6,8,9¶

^¶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.

European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2025 Update*

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Evaluating Quality Improvement Initiatives for Respiratory Distress

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Find the answers to frequently asked questions about RDS and surfactant therapy in preterm infants—and more.

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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.

AAP=American Academy of Pediatrics; AUC=area under the curve; CPAP=continuous positive airway pressure; C-section=cesarean section; EU=European Union; FiO₂=fraction of inspired oxygen; GA=gestational age; NICU=neonatal intensive care unit; RDS=respiratory distress syndrome; ROC=receiver operating characteristic.

References: 1. Fuchs H, Lindner W, Leiprecht A, Mendler MR, Hummler HD. Arch Dis Child Fetal Neonatal Ed. 2011;96(5):F343-F347. 2. De Jaegere AP, van der Lee JH, Cantu C, van Kaam AH. Acta Paediatr. 2021;111(1):54-61. 3. Rocha G, Flôr-de-Lima F, Guimarães H. J Perinatol. 2013;33(4):297-301. 4. Dargaville PA, Aiyagari A, De Paoli AG, et al. Neonatology. 2013;104(1):8-14. 5. Kakkilaya V, Wagner S, Mangona KLM, et al. J Perinatol. 2019;39(8):1081-1088. 6. Gulczyńska E, Stępniewska J, Szymankiewicz M, et al. Neonatology. 2019;116(2):171-178. 7. Bahadue FL, Soll R. Cochrane Database Syst Rev. 2012;11(11):CD001456. 8. Sweet DG, Carnielli V, Greisen G, et al. Neonatology. 2026:1-26. 9. Polin RA, Carlo WA; Committee on Fetus and Newborn; American Academy of Pediatrics. Pediatrics. 2014;133(1):156-163. 10. Fathi O, Bapat R, Shepherd EG, Logan JW. In: Chubarova AI, ed. Neonatal Medicine. IntechOpen; 2019. Accessed February 11, 2026. https://www.intechopen.com/chapters/64996 11. Lagoski M, Hamvas A. Surfactant therapy. In: Jain L, Suresh GK, eds. Clinical Guidelines in Neonatology. McGraw Hill; 2019. Accessed April 16, 2026. https://accesspediatrics.mhmedical.com/content.aspx?bookid=2671&sectionid=218701214