Childhood Adenotonsillectomy Trial

7.2.0 Scheduling of AT Surgery

Randomization will occur after final eligibility is confirmed in the Data Management System (DMS). Restricting access of treatment assignments to only the unblinded coordinator and the ENT surgeon will minimize biases. All efforts will be made to keep CHAT study personnel involved with primary data collection blinded to the treatment group (psychometricians, PSG/PRC staff and site PIs). Board-certified otolaryngologists with or without the assistance of resident physicians in accredited otolaryngology training programs will perform the Adenotonsillectomy which will be scheduled through the site’s ENT clinic.

Note: PSG results: All participants enrolled in the study will receive a Polysomnography (PSG) at baseline and month 6. As a safety precaution for all participants who have surgery during the 12 month study period, the PSG Reading Center Core will alert the unblinded coordinator at each site when results fall in the following ranges:

• OAI > 15 or AHI > 20
• Sa02 < 92% for > 2% of sleep time

It is the unblinded coordinator’s responsibility to inform the surgeon in a timely manner by tagging the ENT chart prior to the day of surgery or via a method that is preferable to the site/physician’s practice.