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PEDIATRICS Vol. 106 No. 2 August 2000, pp. 344-345
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ABSTRACT |
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Approval of inhaled nitric oxide by the US Food and Drug Administration for hypoxic respiratory failure of the term and near-term newborn provides an important new therapy for this serious condition. This statement addresses the conditions under which inhaled nitric oxide should be administered to the neonate with hypoxic respiratory failure.
Hypoxic respiratory failure in neonates born at or near
term may be caused by such conditions as primary persistent pulmonary hypertension, respiratory distress syndrome, aspiration syndromes, pneumonia or sepsis, and congenital diaphragmatic hernia. Conventional therapies, which have not been validated by randomized controlled trials, include administration of high concentrations of oxygen, hyperventilation, high-frequency ventilation, the induction of alkalosis, neuromuscular blockade, and sedation.1 Despite
aggressive conventional therapy, neonatal respiratory failure was
associated with a high rate of mortality before the development of
extracorporeal membrane oxygenation (ECMO).2,3 Survival
and short-term morbidity rates have been superior in term and near-term
infants ( Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator for
which the mechanism of action involves guanylyl cyclase activation
leading to production of cyclic guanosine monophosphate and subsequent
smooth muscle relaxation.5-7 Although several studies
have suggested that iNO improves oxygenation,8-14 the US
Food and Drug Administration (FDA) evaluated 2 large randomized multicenter controlled trials of term and near-term neonates with hypoxic respiratory failure that demonstrated improved outcome with iNO
therapy. The Neonatal Inhaled Nitric Oxide Study Group trial documented
that iNO reduced the need for ECMO15 without increasing
neurodevelopmental, behavioral, or medical abnormalities at 2 years of
age.16 These results were strengthened by the Clinical
Inhaled Nitric Oxide Research Group trial, in which iNO reduced the
need for ECMO and the incidence of chronic lung disease.17
iNO was not effective for infants with congenital diaphragmatic hernia.18
The limited data to date on hypoxic preterm neonates suggest that
low-dose iNO improves oxygenation but does not improve
survival.14,19 Additional large randomized trials of iNO
in premature neonates are required because they may experience more
toxic effects than term and near-term infants.14,19,20
It is critical that infants with hypoxic respiratory failure in whom
conventional ventilator therapy fails or is predicted to fail be cared
for in institutions that have immediate availability of
personnel, including physicians, nurses, and respiratory therapists, who are qualified to use multiple modes of ventilation and rescue therapies. Radiologic and laboratory support required to manage the
broad range of needs of these infants is also essential.
iNO should be administered using FDA-approved devices
that are capable of administering iNO in constant concentration ranges in parts per million or less throughout the respiratory cycle. Infants
who receive iNO therapy should be monitored according to
institutionally derived protocols designed to avoid the potential toxic
effects associated with iNO administration. These effects include
methemoglobinemia (secondary to excess nitric oxide concentrations), direct pulmonary injury (attributable to excess levels of nitrogen dioxide), and ambient air contamination.
In the trials of iNO therapy reported to date, the indication for use
has been failure of ventilatory therapy. ECMO, a therapy of
proven efficacy, usually is initiated if iNO therapy fails. Therefore,
institutions that offer iNO therapy generally should have ECMO
capability; if a center lacks ECMO capability, it should work in
collaboration with an ECMO center to prospectively establish appropriate iNO failure criteria and mechanisms for the timely transfer
of infants to the collaborating ECMO center. The diversity of
geography, climate, and transport capabilities necessitates that the
"timely transfer" be dictated by the location-specific transport
limitations as well as the severity of the infant's illness. Because
hypoxic respiratory failure is often rapidly progressive and abrupt
discontinuation of iNO may lead to worsening oxygenation,21 the risk of delayed provision of ECMO must
be considered carefully when determining the appropriate time of
transfer.
Plans for the care and referral of these infants should incorporate the
following recommendations.
34 weeks' gestation) treated with ECMO compared with
conventional therapy4; however, questions remain about the
long-term safety of ECMO.
RECOMMENDATIONS
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Abstract
Recommendation
References
COMMITTEE ON FETUS AND NEWBORN, 1999-2000
James A. Lemons, MD, Chairperson
Lillian R. Blackmon, MD
William P. Kanto, Jr, MD
Hugh M. MacDonald, MD
Carol A. Miller, MD
Warren Rosenfeld, MD
Craig T. Shoemaker, MD
Jane E. Stewart, MD
Michael E. Speer, MD
LIAISON REPRESENTATIVES
Michael F. Greene, MD
American College of Obstetricians and Gynecologists
Patricia Johnson, RN, MS, NNP
American Nurses Association, Association of Women's Health,
Obstetric and Neonatal Nurses, National Association of Neonatal Nurses
Arne Ohlsson, MD
Canadian Paediatric Society
Solomon Iyasu, MBBS, MPH
Centers for Disease Control and Prevention
Linda L. Wright, MD
National Institutes of Health
SECTION LIAISONS
Richard Molteni, MD
Section on Perinatal Pediatrics
Jacob C. Langer, MD
Section on Surgery
STAFF
James Couto, MA
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FOOTNOTES |
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The recommendations in this statement do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.
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ABBREVIATIONS |
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ECMO, extracorporeal membrane oxygenation; iNO, inhaled nitric oxide; FDA, US Food and Drug Administration.
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REFERENCES |
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This article has been cited by other articles:
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  K Khambekar, S Nichani, D K Luyt, G Peek, R K Firmin, D J Field, and H C Pandya Developmental outcome in newborn infants treated for acute respiratory failure with extracorporeal membrane oxygenation: present experience Arch. Dis. Child. Fetal Neonatal Ed., January 1, 2006; 91(1): F21 - F25. [Abstract] [Full Text] [PDF]
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 K. P. Van Meurs, L. L. Wright, R. A. Ehrenkranz, J. A. Lemons, M. B. Ball, W. K. Poole, R. Perritt, R. D. Higgins, W. Oh, M. L. Hudak, et al. Inhaled Nitric Oxide for Premature Infants with Severe Respiratory Failure N. Engl. J. Med., July 7, 2005; 353(1): 13 - 22. [Abstract] [Full Text] [PDF]
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 Committee on Fetus and Newborn Levels of Neonatal Care Pediatrics, November 1, 2004; 114(5): 1341 - 1347. [Abstract] [Full Text] [PDF]
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