A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome

Dani, Carlo; Tálosi, Gyula; Piccinno, Annalisa; Ginocchio, Virginia Maria; Balla, György; Lavizzari, Anna; Straňák, Z; Gitto, Eloisa; Martinelli, Stefano; Plavka, Richard; Królak‐Olejnik, Barbara; Lista, Gianluca; Spedicato, Francesca; Ciurlia, Giorgia; Santoro, Debora; Sweet, David G.

doi:10.1016/j.jpeds.2022.02.054

Cited by 19 publications

(16 citation statements)

References 30 publications

(49 reference statements)

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“…14,15 Since then there have been several aerosolized surfactant clinical trials that have reported variable results. 9,[16][17][18][19][20][21][22] The AERO-02 trial which is the largest aerosolized surfactant clinical trial to date demonstrated that aerosolized calfactant is safe and e cacious. 9 This post hoc analysis of the AERO-02 trial speci cally investigating moderate to late preterm infants revealed that treatment with aerosolized calfactant decreased the need for intubation and liquid surfactant by 51% compared to subjects receiving usual care.…”

Section: Discussionmentioning

confidence: 99%

Response to Aerosolized Calfactant in Infants with Respiratory Distress Syndrome; A Post-hoc Analysis of AERO-02 trial

Kaluarachchi

Zapata

Becker

et al. 2023

Preprint

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Background The largest randomized control trial of aerosolized surfactant (AERO-02 trial) demonstrated a reduction in intubation by 50%. Objective To determine the response after aerosolized calfactant treatment. Methods We conducted a post-hoc analysis of moderate to late preterm neonates in the AERO-02 trial. Trends in hourly fraction of oxygen (FiO2), mean airway pressure (MAP) and respiratory severity score (RSS) were compared between the aerosolized surfactant (AS) and usual care (UC) groups. Results Forty-eight percent of subjects in the UC group required intubation compared to 24% in the AS group. FiO2, MAP and RSS were lower in the UC group. FiO2 decrease was seen after the first aerosolized calfactant dose. Conclusion FiO2, MAP and RSS were lower in the UC group. This is likely due to early and higher rate of liquid surfactant administration in the UC group. Decrease in FiO2 was noted in the AS group after the first aerosolization.

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Section: Discussionmentioning

confidence: 99%

Response to Aerosolized Calfactant in Infants with Respiratory Distress Syndrome; A Post-hoc Analysis of AERO-02 trial

Kaluarachchi

Zapata

Becker

et al. 2023

Preprint

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“…Up so far, six published clinical studies have investigated whether non-invasive aerosol delivery of animal-derived (clinical) surfactant can prevent the need for early intubation for invasive mechanical ventilation and/or intratracheal surfactant instillation ( 57 – 62 ). Three studies showed a significant reduction in nCPAP failure ( 57 , 59 , 62 ), two studies ( 58 , 60 ) did not recruit controls but their results pointed in the same direction, and one study ( 61 ) did not show any effectivity, possibly because of air leakage around the nasal prongs. The most recent published study ( 62 ) used a VMN nebulizer with breath-actuation of surfactant delivery and suggests that a double dose of clinical surfactant given at the right time of the respiratory cycle may be the way forward in non-invasive surfactant administration in preterm infants with RDS who are supported with nCPAP ventilation.…”

Section: Findings From Animal and Clinical Studiesmentioning

confidence: 96%

Aerosol Delivery of Lung Surfactant and Nasal CPAP in the Treatment of Neonatal Respiratory Distress Syndrome

Walther

Waring²

2022

Front. Pediatr.

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After shifting away from invasive mechanical ventilation and intratracheal instillation of surfactant toward non-invasive ventilation with nasal CPAP and less invasive surfactant administration in order to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome, fully non-invasive surfactant nebulization is the next Holy Grail in neonatology. Here we review the characteristics of animal-derived (clinical) and new advanced synthetic lung surfactants and improvements in nebulization technology required to secure optimal lung deposition and effectivity of non-invasive lung surfactant administration. Studies in surfactant-deficient animals and preterm infants have demonstrated the safety and potential of non-invasive surfactant administration, but also provide new directions for the development of synthetic lung surfactant destined for aerosol delivery, implementation of breath-actuated nebulization and optimization of nasal CPAP, nebulizer circuit and nasal interface. Surfactant nebulization may offer a truly non-invasive option for surfactant delivery to preterm infants in the near future.

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“…Results on the efficacy and feasibility of nebulized surfactant is emerging (148). In a recent randomized controlled trial, nebulized surfactant did not differ from CPAP alone in preventing CPAP failure, however with advances in nebulization/aerosolization devices and surfactant formulations, this modality may have promise (149).…”

Section: Surfactantmentioning

confidence: 99%

Respiratory distress syndrome management in resource limited settings—Current evidence and opportunities in 2022

et al. 2022

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The complications of prematurity are the leading cause of neonatal mortality worldwide, with the highest burden in the low- and middle-income countries of South Asia and Sub-Saharan Africa. A major driver of this prematurity-related neonatal mortality is respiratory distress syndrome due to immature lungs and surfactant deficiency. The World Health Organization's Every Newborn Action Plan target is for 80% of districts to have resources available to care for small and sick newborns, including premature infants with respiratory distress syndrome. Evidence-based interventions for respiratory distress syndrome management exist for the peripartum, delivery and neonatal intensive care period- however, cost, resources, and infrastructure limit their availability in low- and middle-income countries. Existing research and implementation gaps include the safe use of antenatal corticosteroid in non-tertiary settings, establishing emergency transportation services from low to high level care facilities, optimized delivery room resuscitation, provision of affordable caffeine and surfactant as well as implementing non-traditional methods of surfactant administration. There is also a need to optimize affordable continuous positive airway pressure devices able to blend oxygen, provide humidity and deliver reliable pressure. If the high prematurity-related neonatal mortality experienced in low- and middle-income countries is to be mitigated, a concerted effort by researchers, implementers and policy developers is required to address these key modalities.

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A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome

Cited by 19 publications

References 30 publications

Response to Aerosolized Calfactant in Infants with Respiratory Distress Syndrome; A Post-hoc Analysis of AERO-02 trial

Response to Aerosolized Calfactant in Infants with Respiratory Distress Syndrome; A Post-hoc Analysis of AERO-02 trial

Aerosol Delivery of Lung Surfactant and Nasal CPAP in the Treatment of Neonatal Respiratory Distress Syndrome

Respiratory distress syndrome management in resource limited settings—Current evidence and opportunities in 2022

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