Childhood Adenotonsillectomy Trial

7.2.2 Watchful Waiting Supportive Care (WWSC) – Unblinded “Open Label” Phase

Participants in the WWSC group will have a re-evaluation clinical visit with an otolaryngologist which should be scheduled at the time of randomization. The re-evaluation will occur 1-4 weeks after the 7-month primary end point visit. Symptoms and PSG findings (baseline and month 7) will be available to the otolaryngologist and reviewed to determine surgical candidacy. If the subject is still deemed a candidate for AT after re-evaluation by ENT, AT surgery will be scheduled within 1-4 weeks after their re-evaluation visit (refer to bulleted list below). Scheduling surgery for study patients within the specified time frame will be facilitated as needed by the lead otolaryngologist at each clinical site, who will also be available to address any persistent scheduling issues.

During the “open label” follow-up period subjects in the WWSC arm will have AT surgery scheduled as follows:

• After the Month 7 visit has been conducted and all data has been entered into the DMS to assure that blinding is maintained throughout the primary endpoint. and
• After the ENT Re-Evaluation has been performed.