WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

June 1, 2025

Study Completion Date

June 1, 2025

Conditions
Pediatric Cancer
Interventions
BEHAVIORAL

WASPE Sleep Adjustment Protocol

Parents are instructed to implement the WASPE protocol (Watching videos, Activities outdoors, Stimulation to stay awake, Playing with toys, and Eating snacks) to keep the child awake from morning until the scheduled RT slot (14:00-16:00), thereby inducing natural deep sleep during RT without pharmacologic sedation. Treatment setup is verified with CBCT and monitored in real time using OSMS with a 5-mm motion threshold.

DRUG

Chloral Hydrate

Oral or rectal chloral hydrate (typically 30-50 mg/kg, maximum 1 g) administered approximately 30 minutes before each RT fraction per institutional pediatric sedation protocol. Vital signs are monitored continuously. CBCT and OSMS are used as in the experimental arm.

Trial Locations (1)

0531

Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan

All Listed Sponsors
lead

Shandong Cancer Hospital and Institute

OTHER

NCT06443632 - WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy | Biotech Hunter | Biotech Hunter