Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial.

BACKGROUND: At birth, the majority of neonates born at <30 weeks of gestation require respiratory support to facilitate transition and ensure adequate gas exchange. Although the optimal approach to the initial respiratory management is uncertain, the American Academy of Pediatrics endorses noninvasive respiratory support with nasal continuous positive airway pressure (nCPAP) for premature neonates with respiratory insufficiency. Despite evidence for its use, nCPAP failure, requiring intubation and mechanical ventilation, is common. Recently, investigators have described a novel method to deliver bubble nCPAP, termed Seattle-PAP. While preclinical and pilot studies are encouraging regarding the potential value of Seattle-PAP, a large trial is needed to compare Seattle-PAP directly with the current standard of care for bubble nCPAP (Fisher & Paykel CPAP or FP-CPAP). METHODS/DESIGN: We designed a multicenter, non-blinded, randomized controlled trial that will enroll 230 premature infants (220/7 to 296/7 weeks of gestation). Infants will be randomized to receive Seattle-PAP or FP-CPAP. The primary outcome is respiratory failure requiring intubation and mechanical ventilation. Secondary outcomes include measures of short- and long-term respiratory morbidity and cost-effectiveness. DISCUSSION: This trial will assess whether Seattle-PAP is more efficacious and cost-effective than FP-CPAP in real-world practice among premature neonates. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03085329 . Registered on 21 March 2017.

Improving the Prediction of Neonatal Outcomes in Isolated Left-Sided Congenital Diaphragmatic Hernia by Direct and Indirect Sonographic Assessment of Liver Herniation.

OBJECTIVES: Liver herniation can be assessed sonographically by either a direct (liver-to-thoracic area ratio) or an indirect (stomach position) method. Our objective was to evaluate the utility of those methods to assess liver herniation for the prediction of neonatal outcomes in patients with isolated left-sided congenital diaphragmatic hernia (CDH). METHODS: We conducted a retrospective cohort study of all patients with CDH who had prenatal assessment and were delivered at Texas Children's Hospital between January 2004 and April 2014. The predictive value of sonographic parameters for mortality and the need for extracorporeal membrane oxygenation was evaluated by univariate, multivariate, and factor analysis and by receiver operating characteristics curves. RESULTS: A total of 77 fetuses with isolated left-sided CDH were analyzed. The lung-to-head ratio, liver-to-thorax ratio, and stomach position (according to the classifications of Kitano et al [Ultrasound Obstet Gynecol 2011; 37:277-282] and Cordier et al [J Matern Fetal Neonatal Med 2015; 28:190-195]) were significantly associated with both neonatal outcomes (P < .03). Significant correlations were observed between all of these sonographic parameters. A combination of the liver-to-thorax ratio and stomach position (Kitano) or stomach position (Cordier) with the lung-to-head ratio increased the area under the receiver operating characteristic curve of the lung-to-head ratio for mortality prediction (0.86 [95% confidence interval, 0.74-0.98], 0.83 [0.72-0.95], and 0.83 [0.74-0.92], respectively). CONCLUSIONS: Sonographic measurements of liver herniation (liver-to-thorax ratio and stomach position) are predictive of neonatal outcomes in isolated left-sided congenital diaphragmatic hernia. Our study shows that the combination of those sonographic measurements of liver herniation and lung size improves the accuracy of predicting mortality in those fetuses.