Trial Outcomes & Findings for Pediatric Adenotonsillectomy Trial for Snoring (NCT NCT02562040)

Results Overview

The BRIEF GEC section comprises summary measures of behavioral regulation, emotion regulation, and cognitive regulation (BRIEF-2, for children aged 5 to 18 years) or inhibitory self-control, flexibility, and emergent metacognition (BRIEF-P, for preschool-aged children). These scores are linear transformations of the raw scores (mean = 50, sd = 10) where a higher T score indicates a child has a lower capacity to organize and self-regulate.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

459 participants

Primary outcome timeframe

12 months

Results posted on

2024-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Watchful Waiting With Supportive Care All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities. Watchful Waiting with Supportive Care (WWSC): Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities Early Adenotonsillectomy (eAT): Standard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Overall Study STARTED	228	231
Overall Study 6-month Visit	189	188
Overall Study COMPLETED	199	196
Overall Study NOT COMPLETED	29	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Watchful Waiting With Supportive Care All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities. Watchful Waiting with Supportive Care (WWSC): Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities Early Adenotonsillectomy (eAT): Standard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Overall Study Lost to Follow-up	20	28
Overall Study Withdrawal by Subject	8	7
Overall Study Adverse Event	1	0

Baseline Characteristics

Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

The BRIEF GEC section comprises summary measures of behavioral regulation, emotion regulation, and cognitive regulation (BRIEF-2, for children aged 5 to 18 years) or inhibitory self-control, flexibility, and emergent metacognition (BRIEF-P, for preschool-aged children). These scores are linear transformations of the raw scores (mean = 50, sd = 10) where a higher T score indicates a child has a lower capacity to organize and self-regulate.

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=197 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=195 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score	-1.90 change in score on a scale Standard Deviation 8.62	-3.08 change in score on a scale Standard Deviation 9.39

PRIMARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

Performance on combined Go-No-Go (GNG)/Continuous Performance Test (CPT) task was assessed by tracking accuracy responses to targets (fish) and false positive responses to non-targets (sharks). d' is computed for both portions of the task as an assessment of accuracy in making correct detections adjusting for the participant's tendency to respond to non-targets. The adjusted measure is computed by subtracting Z-scores for false positive responses from Z-scores for correct detections. Individual Z-scores were based on a child's performance within same age groups (3-4, 5-6 , and \>=7 years old). Scores ranged across age groups from -0.53 to 3.99 for GNG and -0.61 to 4.35 for CPT. Higher scores reflect better discrimination of targets from non-targets. A value of 4.65 represents 100% accuracy, 0 represents chance performance, and minus scores represent more frequent detection of non-targets than targets, suggesting a child misunderstood instructions or preferred responding to non-targets.

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=182 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=182 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d').	1.9 d-prime Standard Deviation 8.6	3.1 d-prime Standard Deviation 9.4

SECONDARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

Fine motor coordination assessed by the time (in seconds) it takes a child to complete the NIH-Toolbox 9-Hole Pegboard Dexterity Test. Shorter times indicate greater dexterity. The reported value is the average of the dominant and non-dominant hand scores.

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=183 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=187 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time	-5.9 change in seconds Standard Deviation 8.0	-5.3 change in seconds Standard Deviation 7.4

SECONDARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

Behavior assessed by the change from baseline to 12 months in the caregiver-reported Child Behavior Checklist (CBCL) overall summary score T scores. The T scores are standardized transformations of the raw score (mean = 50, sd = 10), where a higher scores indicate greater problems.

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=182 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=183 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Child Behavior Checklist (CBCL) Summary Scale T Scores	-1.44 change in score on a scale Standard Deviation 7.54	-4.55 change in score on a scale Standard Deviation 9.00

SECONDARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

The PSQ-SRBD scale is a 22-item questionnaire which includes three subscales: snoring, daytime sleepiness, and hyperactive behaviors/inattention. The PSQ-SRBD is commonly used to assess sleep-disordered breathing (SDB) risk in pediatric patients, but is also increasingly used to assess symptom burden. Higher scores correspond to greater SDB symptoms and the total range is 0-1

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=193 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=187 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) Total Score.	-0.07 change in score on a scale Standard Deviation 0.16	-0.23 change in score on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

The Epworth Sleepiness Scale (ESS) Modified for Children is an 8-item validated questionnaire which evaluates excessive daytime sleepiness. The wording and questions are revised from the original ESS to be more suitable for children. The total score has a range from 0-24 where higher values indicate greater sleepiness.

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=193 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=184 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Sleepiness Measured by Change in the Epworth Sleepiness Scale (ESS) Modified for Children Summary Score.	-0.67 change in score on a scale Standard Deviation 4.39	-1.77 change in score on a scale Standard Deviation 4.95

SECONDARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

General quality of life assessed by caregiver reported PedsQL total score and subscores (Psychosocial Health Summary Score \& Physical Health Summary Score). The PedsQL Total Score comprises performance on 4 subscales: emotional functioning, social functioning, school functioning (summarized by the Psychosocial Functioning Score) and physical functioning (summarized by the Physical Functioning score). Scores on all scales range from 0 to 100, with higher scores indicating an increased quality of life.

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=193 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=187 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. Parent - Total	-2.62 change in score on a scale Standard Deviation 15.02	2.09 change in score on a scale Standard Deviation 14.95
Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. Parent - Physical	-5.34 change in score on a scale Standard Deviation 24.32	0.74 change in score on a scale Standard Deviation 23.55
Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. Parent - Psychosocial	-1.08 change in score on a scale Standard Deviation 13.33	2.85 change in score on a scale Standard Deviation 14.17

SECONDARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

The OSA-18 is a disease-specific QOL survey that captures symptoms across five domains: sleep disturbance, physical suffering, emotional distress, daytime problems, and parent/caretaker concerns. With a Likert 7-point scale, caregivers rate the perceived frequency of 18 OSA-related problems ranging from 1 (none of the time) to 7 (all the time). Scores on each item are summed to produce a total score ranging from 18 to 126. Higher scores correspond to poorer sleep disordered breathing-related QOL, with a score greater than or equal to 60 signifying a clinically meaningful negative impact of sleep disordered breathing on QOL

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=193 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=186 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) Total Score.	-6.03 change in score on a scale Standard Deviation 14.59	-15.77 change in score on a scale Standard Deviation 14.42

SECONDARY outcome

Timeframe: 12 months

Population: All participants with 3 valid height and weight measurements at both baseline and 12-months are included

Body Mass Index (BMI) percentile, calculated from the average of triplicate in-clinic height/weight measurements. Percentiles calculated from Centers for Disease Control and Prevention (CDC) BMI-for-age charts.

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=188 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=187 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Body Mass Index (BMI) Percentile	3.23 change in percentile Standard Deviation 13.31	5.09 change in percentile Standard Deviation 14.32

SECONDARY outcome

Timeframe: 12 months

Population: All participants with 3 valid measurements at both baseline and 12-months are included

Mean of blood pressures measured in triplicate (to 1.0 mmHg) via automated oscillometric blood pressure cuff. Percentiles calculated respective to height, age and sex (PMID: 18230679).

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=177 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=173 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores. Systolic	4.75 Change in percentile Standard Deviation 31.4	-4.5 Change in percentile Standard Deviation 28.9
Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores. Diastolic	2.20 Change in percentile Standard Deviation 20.79	-4.87 Change in percentile Standard Deviation 22.52

SECONDARY outcome

Timeframe: 12 months

Population: All participants with valid measurements at both baseline and 12-months are included

Average heart rate (beats per minute) calculated from overnight polysomnography

Outcome measures

Outcome measures
Measure	Watchful Waiting With Supportive Care n=152 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=154 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Change From Baseline to 12 Months in Average Heart Rate	-1.80 change in avg bpm Standard Deviation 7.92	-1.97 change in avg bpm Standard Deviation 7.68

Adverse Events

Watchful Waiting With Supportive Care

Serious events: 9 serious events

Other events: 112 other events

Deaths: 0 deaths

Early Adenotonsillectomy

Serious events: 13 serious events

Other events: 103 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Watchful Waiting With Supportive Care n=228 participants at risk All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=231 participants at risk All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Gastrointestinal disorders Vomiting	6.6% 15/228 • Number of events 15 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	5.3% 12/228 • Number of events 17 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	7.4% 17/231 • Number of events 18 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Respiratory, thoracic and mediastinal disorders Streptococcal sore throat	13.2% 30/228 • Number of events 40 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	5.6% 13/231 • Number of events 14 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Gastrointestinal disorders Stomach virus	7.0% 16/228 • Number of events 19 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	7.8% 18/231 • Number of events 19 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Postoperative pain	0.00% 0/228 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	5.2% 12/231 • Number of events 14 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Respiratory, thoracic and mediastinal disorders Influenza	5.7% 13/228 • Number of events 13 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	8.2% 19/231 • Number of events 20 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
General disorders Fever	11.4% 26/228 • Number of events 34 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	6.9% 16/231 • Number of events 20 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Respiratory, thoracic and mediastinal disorders Exacerbation of asthma	0.00% 0/228 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	6.1% 14/231 • Number of events 16 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Ear and labyrinth disorders Ear infection	11.0% 25/228 • Number of events 29 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	6.9% 16/231 • Number of events 21 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Respiratory, thoracic and mediastinal disorders Common cold	11.8% 27/228 • Number of events 35 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	11.3% 26/231 • Number of events 27 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.

Additional Information

Dr. Susan Redline

Brigham and Women's Hospital

Phone: (617) 732-5500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Watchful Waiting With Supportive Care n=227 Participants All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=231 Participants All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities	Total n=458 Participants Total of all reporting groups
Age, Continuous	6.15 years STANDARD_DEVIATION 2.36 • n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	6.10 years STANDARD_DEVIATION 2.25 • n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	6.13 years STANDARD_DEVIATION 2.3 • n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Sex: Female, Male Female	111 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	119 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	230 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Sex: Female, Male Male	116 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	112 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	228 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	42 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	75 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Ethnicity (NIH/OMB) Not Hispanic or Latino	194 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	189 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	383 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	0 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	0 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	2 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	3 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Race (NIH/OMB) Asian	5 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	3 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	8 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	0 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	0 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Race (NIH/OMB) Black or African American	63 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	60 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	123 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Race (NIH/OMB) White	148 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	155 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	303 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Race (NIH/OMB) More than one race	10 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	10 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	20 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	1 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	1 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Apnea-Hypopnea Index	0.6 events per hour n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	0.5 events per hour n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	0.5 events per hour n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)
Asthma	55 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	53 Participants n=7 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)	108 Participants n=5 Participants • Primary analysis includes all PATS participants other than one child who was randomized from Boston Children's Hospital (site's only participant was lost to follow-up and site closed early)

Measure	Watchful Waiting With Supportive Care n=228 participants at risk All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.	Early Adenotonsillectomy n=231 participants at risk All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Injury, poisoning and procedural complications Arm fracture	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	1.3% 3/231 • Number of events 3 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Broken ankle	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Buckle fracture	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Closed fracture of clavicle	0.00% 0/228 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.43% 1/231 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Closed fracture of unspecified part of fibula	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Closed fracture of unspecified part of tibia	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Respiratory, thoracic and mediastinal disorders Croup	0.00% 0/228 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.43% 1/231 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/228 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.43% 1/231 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Respiratory, thoracic and mediastinal disorders Exacerbation of asthma	0.44% 1/228 • Number of events 2 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Fracture of humerus, supracondylar closed	0.00% 0/228 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.43% 1/231 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Metabolism and nutrition disorders Ketotic hypoglycemia	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Social circumstances Physical abuse	0.00% 0/228 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.43% 1/231 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Infections and infestations Pneumonia	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Postprocedural bleeding	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	2.2% 5/231 • Number of events 5 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.
Injury, poisoning and procedural complications Wrist fracture	0.44% 1/228 • Number of events 1 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.	0.00% 0/231 • Adverse event data was collected from the date of the first consent through study completion, an average of 12 months with a maximum time frame of 425 days from consent.