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Breathe Right Nasal Strips and SIDS

Tue, 14 Jan 1997

Greetings to all,

Someone mentioned recently that they'd seen an article mentioning Breathe Right Nasal Strips and SIDS.

I've just reviewed the original article. It was in the Journal of Pediatrics, volume 129, pages 804-808, 1996, by Scharf et al.

Basically, they took 15 normal infants 2-4 months of age and did daytime (1.5 hour nap) sleep studies on them with and without the external nasal dilator strip in place. They also studied an additional group of 5 infants with "colds" in the same manner. They found no differences with respect to sleep, with or without the strips. They found *no* difference, with or without the strips, when they looked at obstructive apnea (upper airway obstruction, obstructive sleep apnea). What they did find was that infants wearing the Breathe Right strips had fewer events that they called partial upper airway obstruction. These were not huge differences... on average without the strips babies had 4.5 so-called partial obstructions versus 2 with the Breathe Right device. It sounds so much more dramatic when this is characterized as a "greater than 50% decrease".

The results were essentially the same for the congested group.. the only difference they found was in the number of these so-called partial obstructive events (partial blockage of breathing passages).

In my opinion they way the authors defined and measured the so-called partial obstructions is of questionable validity. These partial obstructive events are difficult to measure in infants and they used methods that, in my view, are unlikely to yield valid results. This was also the opinion of Drs. Givan and Eigen (Indianapolis) who published an editorial in the same journal.

I would agree that the one significant finding of this study is questionable, rendering the conclusions of little value at this point. In addition, the issue of safety was not addressed. So, at this point in time, it seems to me that this work has no practical importance for parents. In my view, as was stated in the accompanying editorial (page 781 of same issue), this article does not demonstrate efficacy or safety of these strips for infants.

Because the cause or causes of SIDS are not yet known, the link between SIDS and sleeping position is not yet understood, there is no evidence that normal babies have a "problem" with nasal patency, and because there is no evidence (to my knowledge) that nasal obstruction is a causative factor in SIDS... to link this work at this point with SIDS is a huge unjustified leap. Much to their credit, the authors themselves state that any implication that nasal dilators will reduce the risk of SIDS would be "much too premature" at this time. Of course, the news media is not always so careful to include the caveats and cautions.

I hope this is helpful,

John L. Carroll, M.D.
The Johns Hopkins Children's Center
Baltimore, MD

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