Effectiveness of Intranasal Mometasone Furoate vs Saline for Sleep-Disordered Breathing in Children

Author:

Baker Alice123,Grobler Anneke12,Davies Karen4,Griffiths Amanda125,Hiscock Harriet1267,Kubba Haytham8,Peters Rachel L.12,Ranganathan Sarath125,Rimmer Joanne910,Rose Elizabeth2411,Rowe Katherine3,Simpson Catherine M.127,Davidson Andrew1212,Nixon Gillian1314,Perrett Kirsten P.121215

Affiliation:

1. Department of Paediatrics, University of Melbourne, Melbourne, Australia

2. Murdoch Children's Research Institute, Melbourne, Australia

3. Department of General Medicine, Royal Children’s Hospital, Melbourne, Australia

4. Department of Otolaryngology, Royal Children’s Hospital, Melbourne, Australia

5. Department of Respiratory and Sleep Medicine, Royal Children’s Hospital, Melbourne, Australia

6. Health Services Research Unit, Royal Children’s Hospital, Melbourne, Australia

7. Centre for Community Child Health, Royal Children’s Hospital, Melbourne, Australia

8. Department of Otolaryngology, Royal Hospital for Children, Glasgow, Scotland

9. Department of Otolaryngology–Head and Neck Surgery, Monash Health, Melbourne, Australia

10. Department of Surgery, Monash University, Melbourne, Australia

11. Department of Otolaryngology, University of Melbourne, Melbourne, Australia

12. Melbourne Children’s Trial Centre, Melbourne Children’s, Melbourne, Australia

13. Melbourne Children's Sleep Centre, Monash Children’s Hospital, Monash Health, Melbourne, Australia

14. Department of Paediatrics, Monash University, Melbourne, Australia

15. Department of Allergy and Immunology, Royal Children’s Hospital, Melbourne, Australia

Abstract

ImportanceObstructive sleep-disordered breathing (SDB) in children is characterized by snoring and difficulty breathing during sleep. SDB affects at least 12% of otherwise healthy children and is associated with significant morbidity. Evidence from small clinical trials suggests that intranasal corticosteroids improve SDB as measured by polysomnography; however, the effect on symptoms and quality of life is unclear.ObjectiveTo determine whether intranasal mometasone furoate is more effective than intranasal saline for improving symptoms and quality of life in children with SDB.Design, Setting, and ParticipantsThe MIST trial was a multicenter, randomized, double-blind, placebo-controlled trial, recruiting participants from June 8, 2018, to February 13, 2020. Children aged 3 to 12 years who were referred to a specialist for significant SDB symptoms were included; exclusions were previous adenotonsillectomy, body mass index greater than the 97th percentile, and severe SDB. Randomization was stratified by site, and data were analyzed on an intention-to-treat basis from October 28, 2020, to September 25, 2022.InterventionsParticipants were randomly assigned to receive mometasone furoate, 50 μg, or sodium chloride (saline), 0.9%, 1 spray per nostril daily, dispensed in identical bottles.Main Outcomes and MeasuresThe primary outcome was resolution of significant SDB symptoms (ie, reduction to a level no longer requiring referral to a specialist as per the American Academy of Pediatrics guidelines) at 6 weeks, measured by parental report of symptoms using the SDB Score.ResultsA total of 276 participants (mean [SD] age, 6.1 [2.3] years; 146 male individuals [53%]) were recruited, 138 in each treatment arm. Resolution of significant SDB symptoms occurred 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) with 26 participants lost to follow-up and missing values managed by multiple imputation. 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.Conclusions and RelevanceResults of this randomized clinical trial suggest that there was no difference in treatment effect between intranasal mometasone and saline for the management of SDB symptoms. The results suggest that almost one-half of children with SDB could be initially managed in the primary care setting and may not require referral to specialist services, as is currently recommended.Trial RegistrationAustralian New Zealand Clinical Trials Registry: ANZCTRN12618000448246

Publisher

American Medical Association (AMA)

Subject

Pediatrics, Perinatology and Child Health

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