Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome

Dargaville, Peter A.; Kamlin, C. Omar F.; Orsini, Francesca; Wang, Xiao Fang; Paoli, Antonio G De; Kutman, Hayriye Gözde Kanmaz; Çetınkaya, Merih; Kornhauser‐Cerar, Lilijana; Derrick, Matthew; Özkan, Hilal; Hulzebos, Christian V.; Schmölzer, Georg M.; Aiyappan, Ajit; Lemyre, Brigitte; Kuo, Sheree; Rajadurai, Victor Samuel; O’Shea, Joyce E; Biniwale, Manoj; Ramanathan, Rangasamy; Kushnir, Alla; Bader, David A.; Thomas, Mark R.; Chakraborty, Mallinath; Buksh, Mariam Jan; Bhatia, Risha; Sullivan, Carol L.; Shinwell, Eric S.; Dyson, Amanda; Barker, David; Kugelman, Amir; Donovan, Tim; Tauscher, Markus K.; Murthy, Vadivelam; Ali, Sanoj K. M.; Yossuck, Panitan; Clark, Howard; Soll, Roger F.; Carlin, John B.; Davis, Peter G; Darlow, Brian A; Dunn, Michael; Salter, Amy; Butterley, Karen; Stephens, Nicky; Reid, Lizzy; Dunn, Ross E.; Stephens, Luke; Matzolic, Tammy; Argus, Brenda; Twitchell, Emily; Barrotta, Joanna; Noble, Elizabeth; Tan, Kenneth; Yeomans, Emma; Lai, Melissa; Koorts, Pieter; Broom, Margaret; Law, Brenda Hiu Yan; Cheung, Po–Yin; Os, Sylvia van; Fray, Caroline; Huneault-Purney, Nicole; Faulkner, Melissa Spezia; Horth, Chantal; Grimwood, Rebecca; Riskin, Arieh; Калинина, Татьяна Сергеевна; Tsafrir, C; Afuta, S; Timstut, Fanny; Huth, Sabine; McCaffrey, Frances; Hummler, Helmut; Gupta, Samir; Dinan, Mary; Casiraghi, Maurizio; Yan, Yip Wai; Gopagondanahalli, Krishna Revanna; Chandran, Suresh; Puerta, Rowena Dela; Lučovnik, Miha; Kurtovič, Vlasta L; Olthuis, Annelies J; Baptist, Dyvonne H.; Bouma, Helene A; Büyüktiryaki, Mehmet; Şahin, Suzan; Cebeci, Burcu; Özdemir, Şule; Vantansever, Aylin; McKay, Lorna; McSorley, Therese; Crowley, Philippa; Pond, Jenny; Mellish, C. H.; Hayward, Rachel M; Morris, Ian; Elliot, Sian; Patel, Deena-Shefali; Andrzejewska, Izabela

doi:10.1001/jama.2021.21892

Cited by 101 publications

(94 citation statements)

References 32 publications

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“…In contrast, we found a substantial and sustained decline in BPD rates (ARD −10.7%) between 2010 and 2017, with BPD being defined as a requirement for supplemental oxygen to maintain arterial oxygenation of 90% or more at 36 weeks [25]. Employing a similar physiological definition of BPD, the recent multinational OPTIMIST-A trial demonstrated that surfactant administration without intubation was associated with a significantly reduced incidence of BPD in survivors [21]. The observed ARD (−7.8%) was very similar to that obtained by a previous meta-analysis comparing RCTs that randomized surfactant administration with or without endotracheal intubation (ARD −7.6%) [20].…”

Section: Discussionmentioning

confidence: 99%

“…It is tempting to speculate that the decline of BPD in infants of 24–27 weeks’ gestation might be related in part to the concomitant increase in the fraction of infants managed without endotracheal intubation. Less invasive ventilation may have further contributed to the decline of mortality observed, as suggested by the LISA meta-analysis [20], although LISA did not reduce the rate of death in the most recent OPTIMIST-A trial [21].…”

Section: Discussionmentioning

confidence: 99%

“…This approach has steadily gained acceptance in Germany since first described in 2007 [17], boosted by two RCTs that showed efficacy in reducing the length of mechanical ventilation [18, 19]. A meta-analysis [20] and a recent further large RCT in infants with a gestational age of 25–28 weeks confirmed the association between surfactant administration without endotracheal intubation and reduced rates of BPD [21]. Assuming that published results of large RCTs are likely to influence clinical practice and ultimate outcome, we investigated changes in mortality and morbidities in preterm infants of 24–27 weeks’ gestation born during 2010–2017 in Germany on a population level.…”

Section: Introductionmentioning

confidence: 99%

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Population-Based Outcome Data of Extremely Preterm Infants in Germany during 2010–2017

2022

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Background and Objective: Results of five randomized controlled trials (RCT) sequentially published in 2010–2013 suggested that aiming for higher, as opposed to lower oxygen saturation targets, reduces rates of mortality in infants <28 weeks of gestation, while increasing rates of severe retinopathy of prematurity (ROP). Two further RCTs published in 2011 and 2015 demonstrated that avoiding endotracheal intubation by minimally invasive surfactant administration reduces respiratory morbidity. Assuming that such data are likely to affect clinical practice and ultimate outcome, we analyzed population-level results in extremely preterm infants born across Germany during 2010–2017. Methods: We used mandatory German quality surveillance data to compare mortality and morbidities in preterm infants born between 24 weeks 0 days and 27 weeks 6 days of gestation in 2010–2013 versus 2014–2017. Results: Mortality decreased from 15.1% (1,366/9,058) in 2010–2013 to 12.7% (1,385/10,924) in 2014–2017, risk ratio (RR) 0.845 (95% confidence interval [CI], 0.784–0.901). Rates of severe ROP (≥grade 3) per survivor increased from 12.1% (930/7,692) to 13.3% (1.269/9,539), RR 1.100 (95% CI: 1.017–1.191). The lowest mortality and highest ROP rates were found in infants born in 2014. There was no change in rates of necrotizing enterocolitis, while those of bronchopulmonary dysplasia (BPD) decreased steadily between 2010 and 2017, alongside the increased proportion of infants who were never intubated. Conclusions: There was a moderate decline in mortality, an insignificant increase in severe ROP, and a steady decline of BPD in Germany during 2010–2017. Avoiding endotracheal intubation may have contributed to lowered BPD rates.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Population-Based Outcome Data of Extremely Preterm Infants in Germany during 2010–2017

2022

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“…However, the recently published OPTIMIST-A trial, a multicenter masked RCT that compared surfactant treatment using a thin catheter vs. sham treatment in preterm infants 25 to 28 6/7 weeks of gestation on CPAP, found no difference in the incidence of death or the composite outcome of death or BPD at 36 weeks' PMA between the two groups. The incidence of BPD in survivors was lower in the MIST group ( 47 ).…”

Section: Medications Used In Bpdmentioning

confidence: 82%

Pharmacotherapy in Bronchopulmonary Dysplasia: What Is the Evidence?

Sakaria

Dhanireddy

2022

Front. Pediatr.

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Bronchopulmonary Dysplasia (BPD) is a multifactorial disease affecting over 35% of extremely preterm infants born each year. Despite the advances made in understanding the pathogenesis of this disease over the last five decades, BPD remains one of the major causes of morbidity and mortality in this population, and the incidence of the disease increases with decreasing gestational age. As inflammation is one of the key drivers in the pathogenesis, it has been targeted by majority of pharmacological and non-pharmacological methods to prevent BPD. Most extremely premature infants receive a myriad of medications during their stay in the neonatal intensive care unit in an effort to prevent or manage BPD, with corticosteroids, caffeine, and diuretics being the most commonly used medications. However, there is no consensus regarding their use and benefits in this population. This review summarizes the available literature regarding these medications and aims to provide neonatologists and neonatal providers with evidence-based recommendations.

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“…Most recently, the OPTIMIST-A trial assessed the effectiveness of surfactant administration via MIST in extremely preterm infants with RDS managed on CPAP. The overall composite BPD or death was not significantly reduced in the TCA group compared with CPAP alone (43.6 vs. 49.6%), while death was not significantly different (10 vs. 7.8%), BPD at 36 weeks' postmenstrual age was lower in the MIST group (37.3 vs. 45.3%) ( 62 ).…”

Section: Thin Catheter Administrationmentioning

confidence: 99%

Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA): A Viable Method for Low-Income and Middle-Income Countries

et al. 2022

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Administration of liquid surfactant through an endotracheal tube for the treatment of respiratory distress syndrome has been the standard of care for decades. A skilled health care provider is needed to perform this procedure. In lower-income and middle-income countries (LMICs), healthcare resources are often limited, leading to increased mortality of premature infants, many of whom would benefit from surfactant administration. Therefore, having a simplified procedure for delivery of surfactant without the need for advanced skills could be life-saving, potentially diminish gaps in care, and help ensure more equitable global neonatal survival rates. Modifications to the standard approach of surfactant administration have been put into practice and these include: INtubation-SURfactant-Extubation (INSURE), thin catheter surfactant administration (TCA), aerosolized surfactant, and surfactant administration through laryngeal or supraglottic airways (SALSA). Although there is a need for larger studies to evaluate the comparative effectiveness of these newer methods, these methods are being embraced by the global community and being implemented in various settings throughout the world. Because the SALSA technique does not require laryngoscopy, a provider skilled in laryngoscopy is not required for the procedure. Therefore, because of the ease of use and safety profile, the SALSA technique should be strongly considered as a viable method of delivering surfactant in LMICs.

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Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome

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Cited by 101 publications

References 32 publications

Population-Based Outcome Data of Extremely Preterm Infants in Germany during 2010–2017

Population-Based Outcome Data of Extremely Preterm Infants in Germany during 2010–2017

Pharmacotherapy in Bronchopulmonary Dysplasia: What Is the Evidence?

Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA): A Viable Method for Low-Income and Middle-Income Countries

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