2-056 | Additional Comments | Previous Article | Next Article | List of Articles | Submit Comments | Index | FSN Home Page
Conference Highlights from Hot Topics in
Neonatology Washington, DC; Dec 9-11, 2001
Postnatal Steroids for BPD IV, Session m
oderated by Alan, Jobe MD
New Guidelines for Use of Post-Natal
Dexamethasone in Premature Infants
Coming Soon from the American Academy of Pediatrics Committee on the Fetus and Newborn.
In light of the conclusive evidence that postnatal dexamethasone use is associated with
a significantly increased risk of cerebral palsy and other neuro-developmental problems,
the AAP will be issuing a new practice guideline recommending limiting its use. Ann Stark
MD from Children’s Hospital in Boston reported that the new guidelines will be
published in the February 2002 issue of Pediatrics. These guidelines (which have
also been approved by the Canadian Pediatric Society) will contain the following
recommendations:
- Routine use
of Dexamethasone to prevent or treat chronic lung disease in preterm
infants in not recommended.
- Use should be restricted to randomized, controlled trials.
- Long-term neurodevelopmental follow up of infants treated with Dexa-methasone is
strongly encouraged.
- Insufficient information is available to recommend alternative drugs for this
indication.
- Outside of randomized, controlled trials, use of dexamethasone should be limited to
exceptional circumstances, and only after obtaining informed parental consent
.
Comment. These recommendations will represent the new standard
of care regarding dexamethasone use in preterm babies for the foreseeable future. I
suggest that we heed this advice, or be prepared to face the consequences (medical and
legal).
Let's
have a moment of silence for the passing away of an old friend - dexamethasone. Since the
mid-1980s, we've become too comfortable with this powerful drug. We were so impressed with
its ability to get preterm babies off the ventilator more quickly, that we were willing to
tolerate a wide variety of acute side effects including hypertension, hyperglycemia and GI
bleeding. We became slightly more concerned when we became aware that this drug also
caused poor growth, immune suppression, and focal small bowel perforations. The stake
through the heart for dexamethasone comes with the realization that its use increases the
risk for later development of cerebral palsy by 3-4 fold. Even then, many of us tried to
justify modified use of this drug at lower doses or for briefer courses. It seems we
really liked the idea of getting preterm babies off the ventilator more quickly. Now the
AAP recommends that we restrict the use of this drug in premature babies to randomized
controlled trials and to extreme circumstances with informed parental consent. It's a safe
bet that further controlled studies will never be done. Not many parents would consent to
trying this drug on their preterm babies once they are informed that the drug is more
likely to cause cerebral palsy than it is to prevent chronic lung disease. So Rest in
Peace, old friend. With your passing comes renewed hope for improved neurodevelopmental
outcomes in our premature babies. Remember, "First, do no harm"!
Andrew B. Kairalla MD
Baptist Children's Hospital,, Miami FL
ABKair@aol.com
UserName: David Burchfield, MD
Institution: University of Florida
telephone: 352-392-4195
email: burchdj@mail.peds.ufl.edu
Date: 18 Jan 2002
Time: 08:37:41
Comments:
I read with interest the recommendations that came from the "Hot Topics"
conference concerning dexamethasone for BPD, and that the AAP recommendation that we
restrict the use of this drug in premature babies to randomized controlled trials and to
extreme circumstances with informed parental consents. I am well aware of the data that
shows an increase in CP with dex use, and that for every 8 babies treated, we may cause 1
case of CP. However, I feel that as we, as neonatologists, have done in the past, we
may taking this to another extreme and and may cause more harm than we presently do.
First, the meta-analysis performed throws so many studies together that are so
heterogenious that I cannot make a rational judgemnet of it's validity. Eary and late,
long course and short are all thrown together. And, when this happens, the results
of the larger studies carry so much more weight for the outcome. If the larger
studies were ones of early and protracted use, we may be fooled into thinking all courses
are dangerous. Secondly, I concur that neonatologists jumped on the dex 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
babies who were only moderately ill received steroids and we need to curtail this
practice. However, I feel that steroids have probably been life-saving in some
babies and should be strongly considered for patients with severe pulmonary disease. This
leads me to my third point--parental consent before use. Does anyone feel that the
parents are in a better position to make the judgement 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, should N.O. be used, if
acyclovir be started after perinatal exposure in a low risk circumstance and so on.
Do I feel these are all 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
physcians should come together and decide when these therapies should be applied using the
best data available at that time. I think that in our group of 8 neonatologists at
UF, we can establish criteria for dex use in our NICU that reserves it for patients that
are at high risk for death or severe chronic lung disease. I feel we can make that
judgement better than the parents. I feel that we have the best interests for the
health of their child in mind as we make guidelines for dex use, and that is our primary
responsibility. I do not feel that we should abdicate our decision-making responsibilities
to the families for these issues. It's a slippery slope--today, dexamethasone;
tomorrow, ampicillin? I do feel that we should be talking to our parents and making
them aware of the seriousness of the situation, but I do not agree that it is a decision
that requires parental consent.
UserName: Eric S. Shinwell
Institution: Kaplan Medical Center, Rehovot, Israel
telephone: 972-89441218
email: 972-89441768
Date: 22 Jan 2002
Time: 10:36:33
Comments:
In response to Dr. Burchfield's comments, I would like to point out that the
largest study showing a clear correlation between postnatal dex and CP used only a 3-day
course on days 1-3. This may suggest that even very short courses can cause
significant neurologic damage. So, what is a safe regimen?
Yours
Eric S. Shinwell
Rehovot
Israel
Date: 27 Sep 2002
Time: 12:01:17
I agree with the adverse outcomes reported using, what I call as "industrial"
doses of dexamethasone. There are no studies to my knowledge, evaluating physiological
doses of dexamethasone. I am talking about using 0.05 mg/kg doses for a short period of
time. We have been using this very, low dose dex for a very short period of time. The
total cumulative dose we use is lower than in most of the studies reported. Obviously, we
have severely curtailed the use/abuse of dex. We, like others, are seeing more severe
forms of BPD in our units. I think, we have to be moderate in our decision making.
Abandoning dex all together is not the right way. Certainly, every one agrees that high
doses, or early treatment with dex (< 7 days of age) is more harmful than moderately
early treatment with VERY, VERY low doses of dex for a VERY, VERY short period of time.
UserName: Rangasamy Ramanathan, MD
Institution: Women's and Children's Hospital
telephone: 323-226-3409
email: ramanath@usc.edu
Additional Comments: You may
add your own comments to the discussion of this topic by selecting : Submit Comments.
Return to top