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Hypertonic saline solution – study results for small toddlers

Question
Dear expert team,

Our daughter (now 15 months old) has been inhaling hyptertonic saline solution for 10 months (currently 3ml 3% twice a day, planned to increase to 6%).

Now I came across the results of the following study: “Inhaled hypertonic saline in infants and children younger than 6 years with cystic fibrosis: the ISIS randomized controlled trial.
Rosenfeld M, Ratjen F, Brumback L, Daniel S, Rowbotham R, McNamara S, Johnson R, Kronmal R, Davis SD; ISIS Study Group. JAMA. 2012 Jun 6;307(21):2269-77.“

I am wondering whether further treatment with hypertonic saline solution makes sense. I would be grateful for your assessment including reasons!

Kind regards.
Answer
Hello,

Since your 15-month-old daughter has been inhaling hypertonic saline solution (3%) for 10 months now and a shift to 6% solution is planned, you are wondering whether this is actually sensible at all after reading the ISIS study, which was carried out with 7% hypertonic saline solution in children between 6 months and 6 years of age and did not show any advantage compared to isotonic saline solution.

The following comments have to be made on the study, which was published in the Journal of the American Medical Association:

The following test parameters concerning effectiveness of the 7% solution were chosen: frequency of infections requiring antibiotics therapy during the study; cough frequency and respiratory rate; body weight and size.

Given the age of the study participants, lung function parameters were not tested. The frequency of infections was identical in both trial groups, and no differences were seen concerning cough frequency and respiratory rate or in weight and size development. Due to the selected test parameters, there are controversies around whether it is justified to question the benefit of inhalation with hypertonic saline solution in this age group after this study (see German PO publication muko.info Nr. 3/2012, p. 22). The study would certainly bear greater importance if lung function parameters had been checked. In the participants’ age group, respiratory tract infections are quite common by nature. The decision on whether antibiotics therapy is necessary heavily depends on (strongly subjective) perception and is therefore a soft test parameter. In my opinion, changes in respiratory rate and cough frequency as well as in weight and size development were not to be expected in the control group with a test period of 48 weeks, since the majority of patients could not have had severe lung damage due to their age and therefore the effect of the test therapy could hardly be measurable compared to the therapy with isotonic saline solution.

To me, the study at hand is not sufficient to make inhalation therapy with hypertonic saline solution seem meaningless. The study shows that hypertonic saline solution was tolerated well and that the effect is at least not worse than with inhalation of isotonic saline solution. Since your daughter seems to tolerate the current therapy well, I would like to recommend continuing it. 6% solution can be tried. Since saline solution inhalation is a prophylactic measure, you should not be too strict about having your daughter inhale twice a day imperatively. It is, for instance, perfectly okay to skip inhalation after an exhausting day.

Kind regards,
Dr. H.-G. Posselt
13.12.2012