Clinical Trials of Surfactant Replacement in Europe

Halliday, Henry L.

doi:10.1159/000244445

Cited by 5 publications

(6 citation statements)

References 10 publications

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“…The correlation between surfactant replacement and COD in our population suggests that surfactant therapy could not prevent RDS from developing into BPD. Two meta-analyses 1,27 failed to find that surfactant treatment, regardless of its type or mode, has any direct preventive effect on BPD that seems to be determined multifactorially and is not linked to RDS alone.…”

Section: Discussionmentioning

confidence: 99%

“…New therapies introduced during the past decade have reduced mortality, but their effectiveness in reducing the occurrence of bronchopulmonary dysplasia (BPD) remains controversial. 1 BPD incidence varies in published studies from 4.6% to 72%. 2,3 This broad range may be explained by the heterogeneity of the studied populations, of management practices, or of disease definitions.…”

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confidence: 99%

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Chronic Oxygen Dependency in Infants Born at Less Than 32 Weeks' Gestation: Incidence and Risk Factors

et al. 2001

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ABSTRACT. Objective. To assess incidence and clinical risk factors of chronic oxygen dependency (COD) among survivors who were born at or before 31 weeks' gestation.Methods. This prospective, multicenter study enrolled 802 infants who were born at or before 31 weeks' gestation and admitted to 8 level III neonatal intensive care units in northern and eastern France from January 1 through December 31, 1997. Need for oxygen to maintain oxygen saturation between 92% and 96% was assessed at 28 days of life and at 36 and 42 weeks' postconceptional age (PCA). Stepwise logistic regression analysis was used to identify the incidence of COD and the risk factors related to its occurrence.Results. The mortality rate was 14%. Antenatal corticotherapy was administered to 51% of patients, surfactant therapy to 76% of the ventilated patients, and highfrequency oscillatory ventilation at day 1 to 32%. At 28 days and 36 and 42 weeks' PCA, respectively, 25%, 15%, and 6% of survivors had COD. After adjustment for intercenter variations, we identified the significant risk factors for COD at these dates: a low gestational age, a high score on the Clinical Risk Index for Infants, intrauterine growth restriction, and surfactant treatment.Conclusion. COD incidence was high at 28 days of life but decreased dramatically by 42 weeks' PCA. This study confirmed previously reported risk factors and underlined the importance of intrauterine growth restriction and the Clinical Risk Index for Infants as significant risk factors. Pediatrics 2001;108(2). URL: http://www. pediatrics.org/cgi/content/full/108/2/e26; bronchopulmonary dysplasia, chronic oxygen dependency.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Chronic Oxygen Dependency in Infants Born at Less Than 32 Weeks' Gestation: Incidence and Risk Factors

et al. 2001

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“…We enrolled a total of 412 preterm infants, 237 from the development cohort 9 and 175 from the validation cohort 10 . The characteristics of the study population are shown in Table 1.…”

Section: Resultsmentioning

confidence: 99%

“…This is a secondary analysis of prospectively collected data from 12 neonatal intensive care units (NICUs). Preterm infants between 25° and 33 6 weeks of gestational age (GA) who were enrolled in two previous studies were included after validating their homogeneity 9,10 . Neonates were stratified by GA calculated from the first day of the last menstrual period: 25°− 27 6 ; 28 0 −30 6 ; 31 0 −33 6 weeks.…”

Section: Methodsmentioning

confidence: 99%

Inspired oxygen fraction thresholds to accurately predict surfactant administration in neonatal RDS is gestational age strata: A pragmatic, multi‐center study

Raimondi,

Dolce,

Veropalumbo

et al. 2024

Pediatric Pulmonology

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ObjectiveCurrent international guidelines on neonatal respiratory distress syndrome (RDS) recommend continuous positive airway pressure (CPAP) stabilization as primary treatment. Some guidelines recommend surfactant replacement for babies requiring FiO2 > 0.3 regardless of gestational age (GA). We explore the accuracy of alternative inspired oxygen fraction (FiO2) thresholds as early predictors of surfactant replacement in babies stratified by GA.Study DesignPragmatic, observational study in 12 Italian and Spanish neonatal intensive care units. This is a secondary analysis of data from two cohorts of preterm babies with RDS, stratified by GA (25°− 276; 28°−306; 31°−336) and stabilized on CPAP. FiO2 was collected soon after stabilization and its accuracy to predict subsequent surfactant administration by a rigorously masked physician was assessed.ResultsWe enrolled 412 preterm infants. FiO2 was collected within 2 h of life of life. A cut off of FiO2 > 0.30 failed to identify 50.3% of infants who were later given surfactant by a masked physician. A FiO2 = 0.29 threshold improved sensitivity values to 0.85, 0.79, and 0.61 for the three GA ranges while maintaining specificity of ≥85%. A FiO2 = 0.26 threshold gave sensitivity = 0.83 specificity = 0.79 with GA dependent differences (250−276 sensitivity = 0.90 specificity = 0.80; 280−306 sensitivity = 0.84 specificity = 0.78; 310−336 sensitivity = 0.73 specificity = 0.80).ConclusionsFiO2 is a GA dependent predictor of early surfactant administration. Its accuracy increases when used at lower levels than currently recommended by international guidelines (236 words).

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“…In systematic overviews of trials comparing prophylactic or early administration to surfactant treatment of established respiratory distress syndrome (RDS), infants who received prophylactic or early therapy had a decreased incidence of pneumothorax, pulmonary interstitial emphysema (PIE) and mortality [1,2,3]. Unfortunately, prophylaxis with surfactant would overtreat a large number of infants judged at risk for RDS.…”

Section: Introductionmentioning

confidence: 99%

Early versus delayed surfactant administration in extremely premature neonates with respiratory distress syndrome ventilated by high-frequency oscillatory ventilation

et al. 2002

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Clinical Trials of Surfactant Replacement in Europe

Cited by 5 publications

References 10 publications

Chronic Oxygen Dependency in Infants Born at Less Than 32 Weeks' Gestation: Incidence and Risk Factors

Chronic Oxygen Dependency in Infants Born at Less Than 32 Weeks' Gestation: Incidence and Risk Factors

Inspired oxygen fraction thresholds to accurately predict surfactant administration in neonatal RDS is gestational age strata: A pragmatic, multi‐center study

Early versus delayed surfactant administration in extremely premature neonates with respiratory distress syndrome ventilated by high-frequency oscillatory ventilation

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