To the Editor.—
The recommendations from the American Academy of Pediatrics Committee on Fetus and Newborn concerning use of postnatal steroids to prevent chronic lung disease in premature infants1 is a wonderful review and synopsis of the literature. In general, I applaud the spirit of the recommendation that, in essence, we restrict the use of this drug to a population of infants much sicker than those treated historically. However, I feel that, as was done in the past, we as neonatologists may be taking this to another extreme and may cause more harm by not administering steroids than we presently do.
I concur that neonatologists jumped on the dexamethasone bandwagon with both feet and without thinking through the potential complications clearly. I attended a Neonatal Pharmacology Conference in 1995 where a leader in the field stated, “If you are going to use steroids, use them early.” Obviously, many infants who were only moderately ill received steroids, and we need to curtail this practice. However, steroids have probably been life-saving in some infants and should be strongly considered for patients with severe pulmonary disease. For instance, in the study by Kothadia et al,2 at first glance one would assume that the enrolled patients were quite ill, with an average oxygen requirement at entry of Fio2 (fraction of inspired oxygen) of 0.60. However, the range went as low as Fio2 (fraction of inspired oxygen) of 0.30, a concentration that many would agree should not lead to use of a potentially dangerous medication. More importantly, their data shows a strong trend favoring survival, with only 7 of 57 dexamethasone-treated infants dying compared with 16 of 61 controls (P = .07). Is this a random finding that 9 more infants died who did not get steroids?
This leads me to my major disagreement with the statement—parental consent before use. Does anyone feel that the parents are in a better position to make the judgment about steroid use than the practicing neonatologist? I don’t, just as I don’t feel they are in a better position to choose when, which, and how often to use surfactant, if nitric oxide should be used, or if a cephalosporin should be used instead of an aminoglycoside. Are these important topics that we do not have the ultimate correct answer for at this time? Absolutely. But, to me, it just means that educated, informed physicians should come together and decide when these therapies should be applied using the best data available at that time. I believe that within the group of neonatologists at our institution, we can establish criteria for dexamethasone use in our neonatal intensive care unit, reserving it for patients that are at high risk for death or severe chronic lung disease. Our training and experience have given us more information and knowledge concerning this issue than we could ever impart on the parents. Finally, we have the best interests for the health of children in mind as we make guidelines for dexamethasone use, as is our responsibility.
I do not feel that we should abdicate our decision-making responsibilities to the families for these issues. How many other medications do we use in the neonatal intensive care unit that have been subjected to far less scrutiny than glucocorticoids that also have detrimental side effects? It’s a slippery slope—today, dexamethasone; tomorrow, ampicillin? I do not feel that this is a decision that parents should be forced to make because of the potential guilt that they will be carrying for life. As with all of our critical care therapies that have potentially detrimental as well as beneficial consequences, we should be communicating with the parents and making them aware of the seriousness of the situation. The issue of informed consent for much of the practice of neonatology is an important issue; however, in my opinion, the use of glucocorticoids is not a decision that should require parental consent.
- ↵American Academy of Pediatrics, Committee on Fetus and Newborn. Postnatal corticosteroids to treat or prevent chronic lung disease in preterm infants. Pediatrics.2002;109 :330– 340
- ↵Kothadia JM, O’Shea TM, Roberts D, Auringer ST, Weaver RG, Dillard RG. Randomized placebo-controlled trial of a 42-day tapering course of dexamethasone to reduce the duration of ventilator dependency in very low birth weight infants. Pediatrics.1999;104 :22– 27
- Copyright © 2003 by the American Academy of Pediatrics
We appreciate the opportunity to respond to Dr Burchfield’s thoughtful comments and concerns regarding the impact of the recent statement “Postnatal Corticosteroids to Treat or Prevent Chronic Lung Disease in Preterm Infants,”1 jointly developed by the AAP and the Canadian Paediatric Society Committees on Fetus and Newborn. As with any recommendation to change the management of complex and potentially life-limiting and/or disabling conditions, both committees were aware of the implications for recommending that the “routine” use of corticosteroids be curtailed.
We arrived at this recommendation after very extensive and painstaking review of all of the available published data. Reported use in neonatal intensive care unit networks from both our countries confirmed that approximately 1 in 4 to 5 very low birth weight infants were being exposed to corticosteroids.2,3 Our joint conclusion was that given the current published information on adverse neurodevelopmental outcomes, the potential for harm was greater in exposed infants than in their comparable, unexposed peers. In all of the literature, only a single review revealed a statistically significant survival advantage at 28 days but not at discharge for treated infants.4 We affirm that in most reviews the treated groups had shorter courses of mechanical ventilation,4–8 a desirable good response, however, without a concomitant reduction in chronic lung disease as manifested by a prolonged requirement for oxygen supplementation.
We are surprised at the reaction to the recommendation to inform parents of the current information regarding the potential for adverse complications and neurodevelopmental outcomes and seeking their agreement to the use of corticosteroids in the specific clinical context of treating worsening chronic lung disease. The decision for such use is rarely, if ever, emergent even in the “exceptional clinical circumstances” cited in the recommendation. One would certainly not undertake a surgical intervention for a nonemergent indication, but having a significant adverse complication or outcome risk, without fully informing parents and obtaining their consent. This is not an abdication of the physician decision-making responsibility. It is rather the fulfillment of the responsibility to respect the role of parents to act as surrogate decision-makers for their child. It acknowledges their role in deciding what serves the best interests of that child, particularly when the choice is between which of 2 serious consequences to risk. The parents are not being asked to function as “experts” in determining treatment. We physicians provide the medical expertise and necessary knowledge base and have the responsibility to communicate the information accurately in language understandable to the parents. In doing so we, as professionals, acknowledge that we have limits on our prerogatives to make choices for the future of our patients and their families.
In summary, we continue to believe that current evidence supports the recommendations and that ethical principles require respect for the participation of parents in treatment decisions in intensive care of neonates.
- ↵American Academy of Pediatrics, Committee on Fetus and Newborn. Postnatal steroids to treat or prevent chronic lung disease in preterm infants. Pediatrics.2002;102 :330– 340
- ↵Lee SK, McMillan DD, Ohlsson A, et al. Variations in practice and outcomes in the Canadian NICU Network: 1996–1997. Pediatrics.2000;106 :1070– 1079
- ↵Lemons JA, Bauer CR, Oh W, et al. Very low birth weight outcomes of the National Institutes of Child Health and Human Development Neonatal Research Network, January 1995 through December 1996. Pediatrics.2001;107(1) . Available at: http://www.pediatrics.org/cgi/content/full/107/1/el
- Halliday H. Clinical trials of postnatal corticosteroids: inhaled and systemic. Biol Neonate.1999;76(suppl 1) :29– 40
- Halliday H, Ehrenkrantz RA. Delayed (>3 weeks) postnatal corticosteroids for chronic lung disease in preterm infants (Cochrane Review). Cochrane Database Syst Rev.2001;2 :CD001145
- ↵Shah V, Ohlsson A. Postnatal dexamethasone in the prevention of chronic lung disease. In: David TJ, ed. Recent Advances in Paediatrics 19. London, United Kingdom: Churchill Livingstone; 2001:77–96