Off-label use of inhaled nitric oxide after release of NIH consensus statement

Pediatrics

Volumn 135, Issue 4, 2015, Pages 643-648

  Ellsworth, Marc A ^a   Harris, Malinda N ^a   Carey, William A ^a   Spitzer, Alan R ^b   Clark, Reese H ^b  

^a MAYO CLINIC   (United States)

^b PEDIATRIX MEDICAL GROUP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NITRIC OXIDE;

ARTICLE; BIRTH WEIGHT; CHILD HOSPITALIZATION; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FEMALE; GESTATIONAL AGE; HEALTH CARE UTILIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; NATIONAL HEALTH ORGANIZATION; NEWBORN; NEWBORN CARE; NEWBORN INTENSIVE CARE; OFF LABEL DRUG USE; PREMATURITY; PRESCRIPTION; PRIORITY JOURNAL; CONSENSUS DEVELOPMENT; DRUG UTILIZATION; EXTREMELY LOW BIRTH WEIGHT; INHALATIONAL DRUG ADMINISTRATION; PRACTICE GUIDELINE; RESPIRATORY DISTRESS SYNDROME, NEWBORN; RISK ASSESSMENT; TREATMENT OUTCOME; TRENDS; UNITED STATES; VERY LOW BIRTH WEIGHT;

ADMINISTRATION, INHALATION; DRUG UTILIZATION; FEMALE; GESTATIONAL AGE; GUIDELINE ADHERENCE; HUMANS; INFANT, EXTREMELY LOW BIRTH WEIGHT; INFANT, NEWBORN; INFANT, VERY LOW BIRTH WEIGHT; INTENSIVE CARE UNITS, NEONATAL; MALE; NITRIC OXIDE; OFF-LABEL USE; RESPIRATORY DISTRESS SYNDROME, NEWBORN; RISK ASSESSMENT; TREATMENT OUTCOME; UNITED STATES;

EID: 84927712327     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2014-3290     Document Type: Article

References (36)

1. Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. N Engl J Med. 1997;336(9):597-604
2. Clark RH, Kueser TJ, Walker MW, et al; Clinical Inhaled Nitric Oxide Research Group. Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. N Engl J Med. 2000;342(7):469-474
3. Finer NN, Barrington KJ. Nitric oxide for respiratory failure in infants born at or near term. Cochrane Database Syst Rev. 2006; (4): CD000399
4. Roberts JD Jr, Fineman JR, Morin FC III, et al; The Inhaled Nitric Oxide Study Group. Inhaled nitric oxide and persistent pulmonary hypertension of the newborn. N Engl J Med. 1997;336(9):605-610
5. Clark RH, Ursprung RL, Walker MW, Ellsbury DL, Spitzer AR. The changing pattern of inhaled nitric oxide use in the neonatal intensive care unit. J Perinatol. 2010;30(12):800-804
6. Subhedar NV, Shaw NJ. Changes in oxygenation and pulmonary haemodynamics in preterm infants treated with inhaled nitric oxide. Arch Dis Child Fetal Neonatal Ed. 1997;77(3):F191-F197
7. Kinsella JP, Walsh WF, Bose CL, et al. Inhaled nitric oxide in premature neonates with severe hypoxaemic respiratory failure: a randomised controlled trial. Lancet. 1999;354(9184):1061-1065
8. Srisuparp P, Heitschmidt M, Schreiber MD. Inhaled nitric oxide therapy in premature infants with mild to moderate respiratory distress syndrome. J Med Assoc Thai. 2002;85(suppl 2):S469-S478
9. Schreiber MD, Gin-Mestan K, Marks JD, Huo D, Lee G, Srisuparp P. Inhaled nitric oxide in premature infants with the respiratory distress syndrome. N Engl J Med. 2003;349(22):2099-2107
10. Field D, Elbourne D, Truesdale A, et al; INNOVO Trial Collaborating Group. Neonatal Ventilation With Inhaled Nitric Oxide Versus Ventilatory Support Without Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure: the INNOVO multicentre randomised controlled trial (ISRCTN 17821339). Pediatrics. 2005;115(4):926-936
11. Van Meurs KP, Wright LL, Ehrenkranz RA, et al; Preemie Inhaled Nitric Oxide Study. Inhaled nitric oxide for premature infants with severe respiratory failure. N Engl J Med. 2005;353(1):13-22
12. Hascoet JM, Fresson J, Claris O, et al. The safety and efficacy of nitric oxide therapy in premature infants. J Pediatr. 2005;146(3):318-323
13. Dani C, Bertini G, Pezzati M, Filippi L, Cecchi A, Rubaltelli FF. Inhaled nitric oxide in very preterm infants with severe respiratory distress syndrome. Acta Paediatr. 2006;95(9):1116-1123
14. Kinsella JP, Cutter GR, Walsh WF, et al. Early inhaled nitric oxide therapy in premature newborns with respiratory failure. N Engl J Med. 2006;355(4):354-364
15. Ballard RA, Truog WE, Cnaan A, et al; NO CLD Study Group. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. N Engl J Med. 2006;355(4):343-353
16. Mercier JC, Hummler H, Durrmeyer X, et al; EUNO Study Group. Inhaled nitric oxide for prevention of bronchopulmonary dysplasia in premature babies (EUNO): a randomised controlled trial. Lancet. 2010;376(9738):346-354
17. Askie LM, Ballard RA, Cutter GR, et al; Meta-analysis of Preterm Patients on Inhaled Nitric Oxide Collaboration. Inhaled nitric oxide in preterm infants: an individual-patient data meta-analysis of randomized trials. Pediatrics. 2011;128(4):729-739
18. Barrington KJ, Finer N. Inhaled nitric oxide for respiratory failure in preterm infants. Cochrane Database Syst Rev. 2010; (12): CD000509
19. Donohue PK, Gilmore MM, Cristofalo E, et al. Inhaled nitric oxide in preterm infants: a systematic review. Pediatrics. 2011;127 (2). Available at: www.pediatrics.org/cgi/content/full/127/2/e414
20. Watson RS, Clermont G, Kinsella JP, et al; Prolonged Outcomes After Nitric Oxide Investigators. Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year. Pediatrics. 2009;124(5):1333-1343
21. Padula MA, Grover TR, Brozanski B, et al. Therapeutic interventions and shortterm outcomes for infants with severe bronchopulmonary dysplasia born at, 32 weeks' gestation. J Perinatol. 2013;33(11):877-881
22. Cole FS, Alleyne C, Barks JD, et al. NIH Consensus Development Conference statement: inhaled nitric-oxide therapy for premature infants. Pediatrics. 2011;127(2):363-369
23. Kumar P; Committee on Fetus and Newborn; American Academy of Pediatrics. Use of inhaled nitric oxide in preterm infants. Pediatrics. 2014;133(1):164-170
24. Truog WE, Nelin LD, Das A, et al; NICHD Neonatal Research Network. Inhaled nitric oxide usage in preterm infants in the NICHD neonatal research network: intersite variation and propensity evaluation. J Perinatol. 2014;34(11):842-846
25. Spitzer AR, Ellsbury DL, Handler D, Clark RH. The Pediatrix BabySteps Data Warehouse and the Pediatrix QualitySteps improvement project system-tools for "meaningful use" in continuous quality improvement. Clin Perinatol. 2010;37(1):49-70
26. Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics. 2006;117(6):1979-1987
27. Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Empiric use of ampicillin and cefotaxime, compared with ampicillin and gentamicin, for neonates at risk for sepsis is associated with an increased risk of neonatal death. Pediatrics. 2006;117(1):67-74
28. Hintz SR, Van Meurs KP, Perritt R, et al Neurodevelopmental outcomes of premature infants with severe respiratory failure enrolled in a randomized controlled trial of inhaled nitric oxide. J Pediatr. 2007;151(1):16-22
29. Skimming JW, Bender KA, Hutchison AA, Drummond WH. Nitric oxide inhalation in infants with respiratory distress syndrome. J Pediatr. 1997;130(2):225-230
30. Van Meurs KP, Rhine WD, Asselin JM, Durand DJ; Preemie NO Collaborative Group. Response of premature infants with severe respiratory failure to inhaled nitric oxide. Pediatr Pulmonol. 1997;24(5):319-323
31. Chock VY, Van Meurs KP, Hintz SR, et al; NICHD Neonatal Research Network. Inhaled nitric oxide for preterm premature rupture of membranes, oligohydramnios, and pulmonary hypoplasia. Am J Perinatol. 2009;26(4):317-322
32. Paneth N, Wallenstein S. Extracorporeal membrane oxygenation and the play the winner rule. Pediatrics. 1985;76(4):622-623
33. Elliott SJ. Neonatal extracorporeal membrane oxygenation: how not to assess novel technologies. Lancet. 1991;337(8739):476-478
34. Carey WA, Colby CE. Extracorporeal membrane oxygenation for the treatment of neonatal respiratory failure. Semin Cardiothorac Vasc Anesth. 2009;13(3):192-197
35. Campbell BT, Herbst KW, Briden KE, Neff S, Ruscher KA, Hagadorn JI. Inhaled nitric oxide use in neonates with congenital diaphragmatic hernia. Pediatrics. 2014;134 (2). Available at: www.pediatrics.org/cgi/content/full/134/2/e420
36. Martin JA, Hamilton BE, Osterman M JK, Curtin SC, Matthews TJ. Births: Final Data for 2012. National Vital Statistics Reports. Vol 62. Hyattsville, MD: National Center for Health Statistics; 2013