Intranasal mometasone furoate was no better than saline for resolving symptoms of sleep-disordered breathing (SDB) in children, but either treatment may reduce the need for specialty care or surgery, the randomized MIST trial suggested.
After 6 weeks of daily treatment, the proportion experiencing the study’s primary endpoint — resolution of significant SDB symptoms — was a similar 44% and 41% with mometasone and saline, respectively (P=0.51), reported Kirsten Perrett, PhD, of the Murdoch Children’s Research Institute at Royal Children’s Hospital in Melbourne, Australia, and colleagues.
And recommendations for surgery decreased sharply in both arms from baseline (62-67%) to 6 weeks (32-38%).
“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,” Perrett’s group concluded in JAMA Pediatrics. “Management with less invasive, cheaper, and readily available treatment would increase the quality of life of children with SDB.”
“Further,” the authors continued, “it would reduce burden on specialist services and therefore allow more timely access for those children who need it most, i.e., those who do not respond to initial primary care medical management. This, in turn, could reduce waiting times and improve care for all children with SDB.”
Whether the study findings represent a treatment effect with mometasone furoate or saline, or simply the natural history of the condition is unclear, is a question that will be explored in MIST+, they noted.
Perrett’s group explained that current American Academy of Pediatrics (AAP) guidelines recommend referring all children with SDB — snoring, difficulty breathing, and other issues during sleep — for management. This may include polysomnography (PSG) or a specialist assessment, with prompt adenotonsillectomy (T&A) recommended for patients with moderate-severe obstructive sleep apnea (OSA).
But the current trial aimed to fill a gap in the management of children who may not have access to PSG, which is limited in many countries; there, the decision to undergo T&A is made on history and clinical examination alone.
“T&A results in improved sleep, quality of life, behavior, and cardiovascular outcomes in the majority of children with SDB symptoms,” wrote Perrett and coauthors. “However, if tested using PSG, 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. Additionally, T&A is painful, costly, and carries a risk of mortality and postoperative morbidity (hemorrhage and respiratory compromise).”
The primary adverse events observed in the current trial included epistaxis (occurring in 9.7% of the mometasone group and 15% of the saline group) and nasal itch or irritation (9.7% and 18%, respectively).
From 2018 to 2020, MIST randomized a total of 276 patients ages 3 to 12 years with SDB to 6 weeks’ of daily intranasal treatment with either mometasone furoate (50 μg) or sodium chloride (0.9%). The primary outcome was defined as a reduction of SDB symptoms to a level no longer requiring a specialist referral as per AAP guidelines.
Average age of participants was 6.1 years, with 53% of patients being boys. All patients were on the respiratory, sleep, or ear, nose, and throat clinic waiting lists at the Royal Children’s Hospital and Monash Children’s Hospitals in Melbourne.
At inclusion, parents of the participants were asked if their child snored, had difficulty breathing while asleep, and if the child had ever experienced apnea while sleeping. Responses were recorded then calculated to produce a summary SDB score, with scores greater than or equal to -1 being the threshold for inclusion in the trial. Scores less than -1 meant the child was categorized as not having significant SDB symptoms.
Patients and their medical backgrounds were also assessed by ear, nose, and throat surgeons and provided recommendations for surgery to address the child’s SDB symptoms. At the time of follow-up, the surgeons were “blinded to the treatment group” and were not told whether the information they examined was from the initial visit or the follow-up.
There were some limitations to the study, including that 26 patients were not present at the time of follow-up. Also, the ear, nose, and throat surgeons did not provide a direct clinical assessment, but examined the patient’s previous medical history and exams, the authors noted.
Peters reported receiving funding from the National Health and Medical Research Council of Australia outside the submitted work. Dr Nixon reported receiving funding from the ResMed Foundation outside the submitted work. Dr Perrett reported receiving grants from the National Health and Medical Research Council of Australia, Immune Tolerance Network, the Royal Children’s Hospital Foundation, the Murdoch Children’s Research Institute, DBV Technologies, Novartis, Siolta, and Aravax outside the submitted work. No other disclosures were reported.
Source Reference: Baker A, et al “Effectiveness of intranasal mometasone furoate vs saline for sleep-disordered breathing in children: a randomized clinical trial” JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2022.5258.