In children with sleep-disordered breathing (SDB), 6 weeks of intranasal saline was just as effective as intranasal mometasone furoate — a corticosteroid agent — in resolving symptoms and reducing urgent surgery, according to study findings published in JAMA Pediatrics.
In children, SDB is characterized by snoring and difficulty breathing during sleep. The disorder has been shown to affect “at least 12% of otherwise healthy children and is associated with significant morbidity,” according to researchers. Although the results from small clinical studies have suggested that the use of intranasal corticosteroids improves SDB, as measured by polysomnography, the effect of this treatment on patients’ symptoms and quality of life (QoL) remains unclear.
The researchers sought to establish whether intranasal mometasone furoate is more effective than intranasal saline for the improvement of symptoms and QoL in children with SDB. They conducted the MIST trial, a multicenter, randomized, double-blind, placebo-controlled study at 2 tertiary hospitals in Melbourne, Australia, with participants recruited from June 8, 2018, through February 13, 2020. Children aged between 3-12 years who had been referred to a specialist for significant symptoms of SDB were included in the study. Randomization was stratified by site, with all data evaluated on an intention-to-treat (ITT) basis from October 28, 2020, to September 25, 2022.
The primary study outcome was resolution of significant SDB symptoms (ie, reduction to a level no longer necessitating referral to a specialist, per the American Academy of Pediatrics guidelines) at 6 weeks, which was measured by parental report of children’s symptoms with use of the SDB score. Secondary outcomes included parent- and surgeon-assessed need for surgery, QoL, behavioral and functional state of the child, and parental satisfaction with treatment.
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[I]t appears possible that a large proportion of children with SBD may be able to be treated successfully by their primary care physician, using 6 weeks of intranasal saline as a first-line treatment.
All of the participants had exhibited ongoing significant symptoms of SDB in the prior
2 weeks, based on parental response to 3 questions:
1) Does your child snore? [S]
2) Does your child have difficulty [D] during sleep? (eg, difficulty breathing, restlessness, gasping or snorting, or waking multiple times in 1 night)
3) Have you seen your child stop breathing while asleep? (ie, an apnea [A] episode).
The first 2 questions were both scored on a 4-point Likert scale (never = 0, sometimes [1-2 nights/week] = 1, often [3-5 nights/week] = 2, or always [6-7 nights/week] = 3). The last question was scored as either yes = 1 or no = 0.
A total of 276 participants were enrolled in the study. The mean patient age was 6.1±
2.3 years. Overall, 146 of the participants were male and 130 were female. The participants were randomly assigned in a 1:1 ratio to receive mometasone furoate 50 μg (n=138) or sodium chloride (saline) 0.9% (n=138), 1 spray in each nostril daily, dispensed in identical-looking bottles.
In all, 11 patients in the mometasone furoate group and 15 in the saline group were lost to follow-up, thus leaving 127 patients and 123 in the respective groups included in the ITT analysis. Resolution of significant SDB symptoms was reported in 44% (56 of 127) of participants in the mometasone arm and 41% (50 of 123) of those in the saline arm (risk difference, 4%; 95% CI, –8% to 16%; P =.51).
The key adverse events reported included epistaxis in 9.7% and 15.0% of patients in the mometasone group and saline group, respectively, as well as nasal itch/irritation in 9.7% and 18.0% of those in the 2 respective groups.
Several limitations of the study warrant mention, including the potential treatment effect of the control arm. Additionally, the surgeon decision-making was based on documented history and examination findings, rather than on their own direct clinical evaluation.
“[I]t appears possible that a large proportion of children with SBD may be able to be treated successfully by their primary care physician, using 6 weeks of intranasal saline as a first-line treatment,” the researchers concluded. “This, in turn, could reduce waiting times and improve care for all children with SDB.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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