Inhaled Nitric Oxide Use in Neonates With Congenital Diaphragmatic Hernia

Campbell, Brendan T.; Herbst, Katherine W.; Briden, Kelleigh E.; Neff, Stephen; Ruscher, Kimberly A.; Hagadorn, James I.

doi:10.1542/peds.2013-2644

Cited by 69 publications

(37 citation statements)

References 31 publications

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“…The ventilation approach, choice of ventilator and the OI at enrollment in this study were different from current practice [33]. In spite of this negative study, iNO continues to be used in US tertiary centers in the management of infants with CDH without a change in ECMO utilization or mortality [91]. If there is no response to iNO after optimizing ventilation and hemodynamic status, iNO is gradually weaned.…”

Section: Reviewmentioning

confidence: 99%

Congenital Diaphragmatic hernia – a review

Chandrasekharan

Rawat

Madappa³

et al. 2017

matern health, neonatol and perinatol

199

151

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Congenital Diaphragmatic hernia (CDH) is a condition characterized by a defect in the diaphragm leading to protrusion of abdominal contents into the thoracic cavity interfering with normal development of the lungs. The defect may range from a small aperture in the posterior muscle rim to complete absence of diaphragm.The pathophysiology of CDH is a combination of lung hypoplasia and immaturity associated with persistent pulmonary hypertension of newborn (PPHN) and cardiac dysfunction. Prenatal assessment of lung to head ratio (LHR) and position of the liver by ultrasound are used to diagnose and predict outcomes. Delivery of infants with CDH is recommended close to term gestation. Immediate management at birth includes bowel decompression, avoidance of mask ventilation and endotracheal tube placement if required. The main focus of management includes gentle ventilation, hemodynamic monitoring and treatment of pulmonary hypertension followed by surgery. Although inhaled nitric oxide is not approved by FDA for the treatment of PPHN induced by CDH, it is commonly used.Extracorporeal membrane oxygenation (ECMO) is typically considered after failure of conventional medical management for infants ≥ 34 weeks’ gestation or with weight >2 kg with CDH and no associated major lethal anomalies. Multiple factors such as prematurity, associated abnormalities, severity of PPHN, type of repair and need for ECMO can affect the survival of an infant with CDH. With advances in the management of CDH, the overall survival has improved and has been reported to be 70-90% in non-ECMO infants and up to 50% in infants who undergo ECMO.

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Section: Reviewmentioning

confidence: 99%

Congenital Diaphragmatic hernia – a review

Chandrasekharan

Rawat

Madappa³

et al. 2017

matern health, neonatol and perinatol

199

151

View full text Add to dashboard Cite

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“…Given the estimated median per day cost of iNO therapy ($5753), 35 this off-label prescription of iNO may have generated a cost to payers of $19.6 million in 2013. The most recent vital statistics report indicates that ∼135 000 infants were born at ,34 weeks' gestation in 2012.…”

Section: Figurementioning

confidence: 99%

Off-Label Use of Inhaled Nitric Oxide After Release of NIH Consensus Statement

et al. 2015

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BACKGROUND: Inhaled nitric oxide (iNO) therapy is an off-label medication in infants ,34 weeks' gestational age. In 2011, the National Institutes of Health released a statement discouraging routine iNO use in premature infants. The objective of this study was to describe utilization patterns of iNO in American NICUs in the years surrounding the release of the National Institutes of Health statement. We hypothesized that iNO prescription rates in premature infants have remained unchanged since 2011.

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“…Treatment with iNO is very costly, with average daily charges greater than $5000. 6 Not surprisingly, CDH is one of the top 5 most expensive conditions treated in the United States, with estimated annual health care costs likely exceeding $250 million. 10 With the growing impetus to provide value-based care, health care systems and clinicians need to reexamine the ongoing use of expensive and unproven treatment strategies.…”

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confidence: 99%

Evaluation of Variability in Inhaled Nitric Oxide Use and Pulmonary Hypertension in Patients With Congenital Diaphragmatic Hernia

et al. 2016

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for the Congenital Diaphragmatic Hernia Study Group IMPORTANCE Inhaled nitric oxide (iNO) is an expensive, commonly used therapy among patients with congenital diaphragmatic hernia (CDH); however, data to support its ongoing use in this patient population are lacking. OBJECTIVE To describe the spectrum of iNO use among patients with CDH and its association with pulmonary hypertension (pHTN) and mortality. DESIGN, SETTING, AND PARTICIPANTSA review was conducted of prospectively collected patient data in the Congenital Diaphragmatic Hernia Study Group registry between January 1, 2007, and December 31, 2014, from 70 participating centers in 13 countries. A total of 3367 newborn infants diagnosed with CDH and entered into the registry were reviewed. On the basis of echocardiogram data, pHTN was defined as right ventricular systolic pressure greater than or equal to two-thirds of the systemic systolic pressure. Propensity score and regression analyses were performed. INTERVENTION Use of iNO.MAIN OUTCOMES AND MEASURES Variability in iNO use and its association with pHTN and mortality. These outcomes were formulated prior to data evaluation.RESULTS Sixty-eight (97.1%) centers used iNO. Of 3367 patients with CDH (1366 [40.6%] females; median estimated gestational age, 38 weeks; range, 23-42 weeks), a total of 2047 (60.8%) received iNO; the mean percentage of those receiving iNO per center was 62.3% (range, 0%-100%). Median iNO dose and duration were 20 (range, 0.1-80) ppm and 8 (range, 0-100) days. Of the 2174 infants with pHTN, 1613 infants (74.2%) received iNO. Of the 943 infants without pHTN, 343 infants (36.4%) were treated with iNO. Based on propensity score analysis incorporating 10 clinically relevant variables, iNO use was significantly associated with increased mortality (average treatment effect on the treated: 0.15; 95% CI, 0.10-0.20). CONCLUSIONS AND RELEVANCEInhaled nitric oxide use is common but highly variable among centers, and 36% of patients without pHTN received iNO therapy. Based on data from 70 centers, iNO use in patients with CDH may be associated with increased mortality. Future efforts should be directed toward data-driven standardization of iNO use to ensure cost-effective practices.

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Inhaled Nitric Oxide Use in Neonates With Congenital Diaphragmatic Hernia

Abstract: WHAT'S KNOWN ON THIS SUBJECT:The role of inhaled nitric oxide (INO)

Cited by 69 publications

References 31 publications

Congenital Diaphragmatic hernia – a review

Congenital Diaphragmatic hernia – a review

Off-Label Use of Inhaled Nitric Oxide After Release of NIH Consensus Statement

Evaluation of Variability in Inhaled Nitric Oxide Use and Pulmonary Hypertension in Patients With Congenital Diaphragmatic Hernia

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