Abstract
BackgroundDespite the considerable amount of evidence from randomized controlled trials and meta-analyses, uncertainty remains regarding the efficacy and safety of high-frequency oscillatory ventilation as compared to conventional ventilation in the early treatment of respiratory distress syndrome in preterm infants. This results in a wide variation in the clinical use of high-frequency oscillatory ventilation for this indication throughout the world. The reasons are an unexplained heterogeneity between trial results and a number of unanswered, clinically important questions. Do infants with different risk profiles respond differently to high-frequency oscillatory ventilation? How does the ventilation strategy affect outcomes? Does the delay – either from birth or from the moment of intubation – to the start of high-frequency oscillation modify the effect of the intervention? Instead of doing new trials, those questions can be addressed by re-analyzing the individual patient data from the existing randomized controlled trials.Methods/DesignA systematic review with meta-analysis based on individual patient data. This involves the central collection, validation and re-analysis of the original individual data from each infant included in each randomized controlled trial addressing this question.The study objective is to estimate the effect of high-frequency oscillatory ventilation on the risk for the combined outcome of death or bronchopulmonary dysplasia or a severe adverse neurological event. In addition, it will explore whether the effect of high-frequency oscillatory ventilation differs by the infant's risk profile, defined by gestational age, intrauterine growth restriction, severity of lung disease at birth and whether or not corticosteroids were given to the mother prior to delivery. Finally, it will explore the importance of effect modifying factors such as the ventilator device, ventilation strategy and the delay to the start of high-frequency ventilation.DiscussionAn international collaborative group, the PreVILIG Collaboration (Prevention of Ventilator Induced Lung Injury Group), has been formed with the investigators of the original randomized trials to conduct this systematic review. In the field of neonatology, individual patient data meta-analysis has not been used previously. Final results are expected to be available by the end of 2009.
Highlights
Despite the considerable amount of evidence from randomized controlled trials and metaanalyses, uncertainty remains regarding the efficacy and safety of high-frequency oscillatory ventilation as compared to conventional ventilation in the early treatment of respiratory distress syndrome in preterm infants
Results of the metaanalyses showed no difference in mortality [relative risk (RR) for death at 36–37 weeks postmenstrual age or discharge: 0.98, 95% confidence interval 0.83– 1.14] and a small but significant reduction in the risk of bronchopulmonary dysplasia (BPD) at 36–37 weeks postmenstrual age or discharge in survivors (RR 0.89, 95% CI 0.81 – 0.99)
The main questions to be addressed by this study are: Identifying studies The trials included in the updated Cochrane review of aggregate data about HFOV [22] will be included in the IPD analysis
Summary
Despite the considerable amount of evidence from randomized controlled trials and metaanalyses, uncertainty remains regarding the efficacy and safety of high-frequency oscillatory ventilation as compared to conventional ventilation in the early treatment of respiratory distress syndrome in preterm infants. This results in a wide variation in the clinical use of high-frequency oscillatory ventilation for this indication throughout the world. Of all infants born at a gestational age of less than 30 weeks, 90% require mechanical ventilation and almost 80% are treated with exogenous surfactant This proportion is highest among the most immature infants [1]. Bronchopulmonary dysplasia is associated with prolonged neonatal intensive care, home oxygen use, recurrent respiratory infections often requiring hospitalization, feeding difficulties with impaired growth and neurodevelopmental delay [7,8,9]
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