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Randomized Controlled Trial
. 2024 Oct 1;150(10):859-867.
doi: 10.1001/jamaoto.2024.2554.

Weight Gain After Adenotonsillectomy in Children With Mild Obstructive Sleep-Disordered Breathing: Exploratory Analysis of the PATS Randomized Clinical Trial

Erin M Kirkham  1 , Stacey Ishman  2 , Cristina M Baldassari  3   4 , Ron B Mitchell  5 , S Kamal Naqvi  6 , Ignacio E Tapia  7 , Lisa M Elden  8 , Fauziya Hassan  9 , Sally Ibrahim  10 , Kristie Ross  10 , Mengqi Cen  11 , Rui Wang  11   12 , Susan Redline  13 , Ronald D Chervin  14
Affiliations
Randomized Controlled Trial

Weight Gain After Adenotonsillectomy in Children With Mild Obstructive Sleep-Disordered Breathing: Exploratory Analysis of the PATS Randomized Clinical Trial

Erin M Kirkham et al. JAMA Otolaryngol Head Neck Surg. .

Abstract

Importance: It is unknown whether adenotonsillectomy causes undesirable weight gain in children with mild obstructive sleep-disordered breathing (oSDB).

Objective: To compare changes in anthropometric measures in children with mild oSDB treated with adenotonsillectomy vs watchful waiting.

Design, setting, and participants: This was an exploratory analysis of the Pediatric Adenotonsillectomy Trial for Snoring (PATS) randomized clinical trial of adenotonsillectomy vs watchful waiting for mild oSDB (snoring with obstructive apnea-hypopnea index of <3 events/hour) that took place at 7 pediatric tertiary care centers across the US and included 458 children aged 3.0 to 12.9 years with mild oSDB. Participants were recruited from June 29, 2016, to February 1, 2021. Anthropomorphic measures taken at baseline and 12 months after randomization were standardized for age and sex, including each participant's percentage of the 95th body mass index percentile (%BMIp95). Data analyses were performed from March 15, 2023, to April 1, 2024.

Intervention: Early adenotonsillectomy (eAT) vs watchful waiting with supportive care (WWSC).

Main outcomes and measures: Twelve-month change in %BMIp95 from baseline and undesirable weight gain (defined as any weight gain in a child who already had overweight or obesity or an increase from baseline normal weight/underweight to overweight/obesity) at follow-up assessment.

Results: The study analysis included 375 children (mean [SD] age, 6.1 [2.3] years; 188 [50.2%] females), of whom 143 (38%) had overweight or obesity at baseline. At 12 months, children in the eAT group experienced a 1.25-point increase in %BMIp95 compared with a 0.59-point increase in the WWSC group (mean difference, 0.93; 95% CI, -0.39 to 2.25). Undesirable weight gain was also similar between the eAT (n = 120; 32%) and WWSC (n = 101; 27%) groups (mean difference, 4%; 95% CI, 5% to 14%).

Conclusions and relevance: The findings of this exploratory analysis of the PATS trial indicate that adenotonsillectomy was not independently associated with an increased risk of undesirable weight gain in children with mild oSDB. However, one-third of the children gained undesirable weight during the study, which suggests that there is an opportunity to address healthy weight management during the evaluation and treatment of children with mild oSDB.

Trial registration: ClinicalTrials.gov Identifier: NCT02562040.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kirkham reported royalties from UpToDate outside the submitted work. Dr Ishman reported consulting fees from Ethicon and Procter & Gamble, and research funding from Nxyoah and Inspire outside the submitted work. Dr Baldassari reported grants from US National Institutes of Health (NIH) during the conduct of the study. Dr Elden reported grants from the NIH during the conduct of the study. Dr Ibrahim reported grants from the NIH (part of same grant supporting the work) during the conduct of the study. Dr Ross reported institutional grants from the NIH during the conduct of the study; grants from AstraZeneca, GlaxoSmithKline, and Sanofi, and personal fees an advisory board meeting outside the submitted work. Dr Wang reported grants from the NIH to institution during the conduct of the study. Dr Redline reported grants from the NIH during the conduct of the study; personal fees from Eli Lilly outside the submitted work; and serving as a board member (unpaid) for the National Sleep Foundation and for the Alliance of Sleep Apnea Partners. Dr Chervin reported institutional grants from the NIH through subcontracts with University of Pennsylvania and Brigham and Women’s Hospital during the conduct of the study; royalties from UpToDate; and consulting fees from Eli Lilly through a contract between company and Michigan Medicine outside the submitted work; in addition, Dr Chervin reported holding a patent and copyrighted material to facilitate diagnosis and treatment of sleep disorder (owned/licensed by University of Michigan to MAPI Questionnaires. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagram of Study Participants
AT indicates adenotonsillectomy; ENT, ear, nose, and throat; and WWSC, watchful waiting with supportive care. aReasons for exclusion included apnea-hypopnea index level out of range; severe, chronic health problems; use of study-restricted medications; no report of habitual snoring; tonsillar size less than 2 on Brodsky scale; and lack of clinical equipoise.
Figure 2.
Figure 2.. Twelve-Month Follow-Up Weight Category by Study Arm Within Groups, Defined by Baseline Weight Category
Weight categories defined by the US Centers for Disease Control and Prevention criteria based on body mass index (calculated as weight in kilograms divided by height in meters squared) z score percentile for age and sex (underweight, <5th percentile; normal weight, 5th to 85th; overweight, >85th to 95th; and obesity, >95th).
See this image and copyright information in PMC

Comment in

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