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The problem
Intervention: Melatonin administered daily for 30 days starting within 72 hours of TBI hospital admission, combined with sleep education handouts and access to educational videos
Who it was tested with: Children aged 6 to 18 years admitted to hospital with traumatic brain injury.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"We conducted a pilot randomized, double-blinded placebo-controlled trial of melatonin for 30 days vs placebo in children aged more than 6 to 18 years started within 72 hours of TBI admission." The randomized design with placebo control provides stronger evidence than observational approaches, though the small sample size and mixed findings across outcome measures limit definitive conclusions.
Study was small (n=21) and not powered to detect effectiveness; objective sleep measurement by actigraphy did not support subjective findings; only 15 of 19 participants provided usable actigraphy data
Across countries and designs
1 study · 1 country
