No difference in treatment efficacy was observed between intranasal mometasone furoate and saline for the management of sleep-disordered breathing (SDB) symptoms in children, with findings indicating that almost one-half of children with SDB could be initially managed in the primary care setting.
Resolution of significant sleep-disordered breathing (SDB) symptoms in children were achieved with intranasal mometasone and saline, with no difference observed between the 2 therapies.
Findings published today in JAMA Pediatrics indicate that SDB could be initially managed in the primary care setting and may not require referral to specialist services, as is currently recommended.
Affecting at least 12% of otherwise healthy children, obstructive SDB is characterized by snoring and difficulty breathing during sleep. SDB is linked with significant morbidity, particularly in the areas of cognitive function, behavior, and cardiovascular health.
Current recommendations for the management of SDB from the American Academy of Pediatrics (AAP) are to refer all children with habitual snoring and other difficulties during sleep for polysomnography (PSG) to determine severity or, if that is not possible, specialist assessment. Pediatric patients with moderate to severe obstructive sleep apnea (OSA) identified via PSG are then recommended to undergo prompt adenotonsillectomy (T&A), which is associated with improved sleep, quality of life, behavior, and cardiovascular outcomes.
However, PSG availability is limited in many countries, and the decision to proceed with surgery is made on history and examination alone in 90% of children. When PSG testing is conducted, approximately one-half of the children referred for T&A have primary snoring without OSA, and evidence is lacking for the benefit of T&A in this group.
“T&A is painful, costly, and carries a risk of mortality and postoperative morbidity (hemorrhage and respiratory compromise),” said the study authors.
“Given the high numbers of children with SDB and the uncertainty of benefit from T&A for those who do not have OSA, alternatives to surgery are needed. Evidence from small clinical trials suggests that intranasal corticosteroids improve SDB as measured by PSG; however, the effect on symptoms and quality of life is unclear.”
Researchers conducted a multicenter, randomized, double-blind, placebo-controlled trial (MIST trial) to determine the safety and efficacy of intranasal corticosteroid, mometasone furoate, for the treatment of symptoms of SBD in children at 6 weeks, as well as compare its effectiveness with intranasal saline.
Eligible participants aged 3 to 12 years who were referred to a specialist for significant SDB symptoms at 2 tertiary hospitals in Melbourne, Australia, were recruited from June 8, 2018, to February 13, 2020. Exclusions were previous adenotonsillectomy, body mass index greater than the 97th percentile, and severe SDB.
Participants were randomly assigned to receive mometasone furoate, 50 μg, or sodium chloride (saline), 0.9%, 1 spray per nostril daily, dispensed in identical bottles. “Randomization was stratified by site, and data were analyzed on an intention-to-treat basis from October 28, 2020, to September 25, 2022,” explained the study authors.
The primary outcome was resolution of significant SDB symptoms (eg, reduction to a level no longer requiring referral to a specialist as per the AAP guidelines) at 6 weeks, measured by parental report of symptoms using the SDB Score. Secondary outcomes included parent- and surgeon-assessed need for surgery, quality of life, behavioral and functional state of the child, and parental satisfaction with treatment.
A total of 276 participants (mean [SD] age, 6.1 [2.3] years; 146 male individuals [53%]) were recruited and randomly assigned to receive either intranasal mometasone furoate (n = 138) or saline (n = 138). At 6 weeks, there were 26 participants lost to follow-up (9.4%).
Using multiple imputation, resolution of significant SDB symptoms was found to occur in 56 of 127 participants (44%) in the mometasone group and 50 of 123 participants (41%) in the saline group (risk difference, 4%; 95% CI, −8% to 16%; P = .51). No significant difference was observed between groups at 6 weeks in symptom scores, quality of life, behavioral function of the child, parent satisfaction with treatment, or the perceived benefit from treatment.
The main adverse effects were epistaxis, affecting 12 of 124 participants (9.7%) in the mometasone group and 18 of 120 participants (15%) in the saline group, and nasal itch/irritation, affecting 12 of 124 participants (9.7%) in the mometasone group and 22 of 120 participants (18%) in the saline group.
Researchers concluded that the follow-up of the MIST trial (MIST+) will examine whether the findings are a result of and equivalence in treatment effect between mometasone and saline or if they reflect natural resolution of the condition.
“It appears possible that a large proportion of children with SDB may be able to be treated successfully by their primary care physician, using 6 weeks of intranasal saline as a first-line treatment,” they said. “Management with less invasive, cheaper, and readily available treatment would increase the quality of life of children with SDB. Further, it would reduce burden on specialist services and therefore allow more timely access for those children who need it most.”
Baker A, Grobler A, Davies K, et al. Effectiveness of intranasal mometasone furoate vs saline for sleep-disordered breathing in children: A randomized clinical trial. JAMA Pediatr. Published online January 17, 2023. doi:10.1001/jamapediatrics.2022.5258