Background Neonates with pulmonary hypertension have been treated with inhaled nitric oxide because of studies suggesting that it is a selective pulmonary vasodilator. We conducted a randomized, multicenter, controlled trial to determine whether inhaled nitric oxide would reduce mortality or the initiation of extracorporeal membrane oxygenation in infants with hypoxic respiratory failure, Methods Infants born after a gestation of greater than or equal to 34 weeks who were 14 days old or less, had no structural heart disease, and required assisted ventilation and whose oxygenation index was 25 or higher on two measurements were eligible for the study. The infants were randomly assigned to receive nitric oxide at a concentration of 20 ppm or 100 percent oxygen (as a control). Infants whose partial pressure of arterial oxygen (PaO2) increased by 20 mm Hg or less after 30 minutes were studied for a response to 80-ppm nitric oxide or control gas, Results The 121 infants in the control group and the 114 in the nitric oxide group had similar base-line clinical characteristics. Sixty-four percent of the control group and 46 percent of the nitric oxide group died within 120 days or were treated with extracorporeal membrane oxygenation (P=0.006). Seventeen percent of the control group and 14 percent of the nitric oxide group died (P not significant), but significantly fewer in the nitric oxide group received extracorporeal membrane oxygenation (39 percent vs. 54 percent, P=0.014). The nitric oxide group had significantly greater improvement in PaO2 (mean [+/-SD] increase, 58.2+/-85.2 mm Hg, vs. 9.7+/-51.7 mm Hg in the controls; P Conclusions Nitric oxide therapy reduced the use of extracorporeal membrane oxygenation, but had no apparent effect on mortality, in critically ill infants with hypoxic respiratory failure. (C) 1997, Massachusetts Medical Society.

Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure

A new method is proposed for making inferences from multinomial data in cases where there is no prior information. A paradigm is the problem of predicting the colour of the next marble to be drawn from a bag whose contents are (initially) completely unknown. In such problems we may be unable to formulate a sample space because we do not know what outcomes are possible. This suggests an invariance principle : inferences based on observations should not depend on the sample space in which the observations and future events of interest are represented. Objective Bayesian methods do not satisfy this principle. This paper describes a statistical model, called the imprecise Dirichlet model, for drawing coherent inferences from multinomial data. Inferences are expressed in terms of posterior upper and lower probabilities. The probabilities are initially vacuous, reflecting prior ignorance, but they become more precise as the number of observations increases. This model does satisfy the invariance principle. Two sets of data are analysed in detail. In the first example one red marble is observed in six drawings from a bag. Inferences from the imprecise Dirichlet model are compared with objective Bayesian and frequentist inferences. The second example is an analysis of data from medical trials which compared two treatments for cardiorespiratory failure in newborn babies. There are two problems : to draw conclusions about which treatment is more effective and to decide when the randomized trials should be terminated. This example shows how the imprecise Dirichlet model can be used to analyse data in the form of a contingency table.

https://rss.onlinelibrary.wiley.com/doi/pdf/10.1111/j.2517-6161.1996.tb02065.x

Inferences from Multinomial Data: Learning About a Bag of Marbles

Extracorporeal membrane oxygenation (ECMO) was used in the treatment of 100 newborn infants with respiratory failure in three phases: Phase I (50 moribund patients to determine safety, efficacy, and risks); Phase II (30 high risk patients to compare ECMO to conventional ventilation); and Phase III (20 moderate to high risk patients, the current protocol). Seventy-two patients survived including 54% in Phase I, 90% in Phase II, and 90% in Phase III. The major complication was intracranial bleeding, which occurred in 89% of premature infants (less than 35 weeks) and 15% of full-term infants. Best survival results were in persistent fetal circulation (10, 10 survived), followed by congenital diaphragmatic hernia (9, 7 survived), meconium aspiration (44, 37 survived), respiratory distress syndrome (26, 13 survived), and sepsis (8, 3 survived). There were seven late deaths; in follow-up, 63% are normal or near normal, 17% had moderate to severe central nervous system dysfunction, and 8% had severe pulmonary dysfunction. ECMO is now used in several neonatal centers as the treatment of choice for full-term infants with respiratory failure that is unresponsive to conventional management. The success of this technique establishes prolonged extracorporeal circulation as a definitive means of treatment in reversible vital organ failure.

Extracorporeal membrane oxygenation (ECMO) in neonatal respiratory failure. 100 cases.

Clinical responses to prolonged treatment of persistent pulmonary hypertension of the newborn with low doses of inhaled nitric oxide

Recently, advances in wearable technologies, data science and machine learning have begun to transform evidence-based medicine, offering a tantalizing glimpse into a future of next-generation ‘deep’ medicine. Despite stunning advances in basic science and technology, clinical translations in major areas of medicine are lagging. While the COVID-19 pandemic exposed inherent systemic limitations of the clinical trial landscape, it also spurred some positive changes, including new trial designs and a shift toward a more patient-centric and intuitive evidence-generation system. In this Perspective, I share my heuristic vision of the future of clinical trials and evidence-based medicine. Technological advances are transforming evidence generation in medicine; for these advances to impact public health, the clinical trial landscape must evolve and adapt to keep pace. 

/pdf/the-next-generation-of-evidence-based-medicine-1bsh6t7e.pdf

The next generation of evidence-based medicine

Fiberoptic Bronchoscopic Nasotracheal Intubation in Children

Extracorporeal membrane oxygenation (ECMO) in the treatment of cardiac and respiratory failure in children.

ECMO support has been evaluated in 29 newborn infants with respiratory failure. Lung function improved in 16 and 13 surivived. Important technical factors include venoarterial bypass with full support capability, careful measurement and treatment of coagulation and platelet status, and a skilled and experienced team. Detecting high risk infants early in life is important. Intracranial bleeding is the most common cause of death.

Extracorporeal membrane oxygenation (ECMO) in newborn respiratory failure: Technical consideration

https://www.annalsthoracicsurgery.org/article/S0003-4975(10)60882-X/pdf

Pseudoaneurysm of the Thoracic Aorta: A Late Complication of Umbilical Artery Catheterization

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