Sleep Management and Recovery After TBI in Kids (SMART-Kids): Pilot Trial Using Melatonin.
Cydni N Williams, Trevor A Hall, Hannah Alberts et al.
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In 30 seconds
This pilot randomized, double-blinded, placebo-controlled trial assessed early melatonin plus sleep education in children aged over 6 to 18 years hospitalized after traumatic brain injury (TBI). Melatonin or placebo was given for 30 days, with sleep education provided to all participants. Of 53 families approached, 21 (40%) consented and 19 (91%) completed the study; 15 (79%) reported medication adherence. The intervention was feasible and acceptable, with no safety concerns identified. At 30 days, clinically important sleep-disturbance scores were more frequent with placebo than melatonin, while actigraphy differences were nonsignificant.
Key findings
- Twenty-one (40%) of 53 approached patients consented, and 19 (91%) completed the study.
- Fifteen (79%) reported medication adherence, defined as ≥5 of 7 days per week.
- Clinically important SDSC scores (T-score ≥60) at 30 days were more frequent with placebo than melatonin; actigraphy differences were nonsignificant.
- The study identified no safety concerns and reported high acceptability.
Why it matters
Sleep disturbance is common after pediatric TBI and may accompany worse cognitive and psychosocial outcomes. This pilot suggests that an early melatonin-and-education approach can be delivered and accepted during recovery, while providing preliminary evidence of a possible sleep benefit. The findings support further evaluation but do not establish effectiveness.
What to keep in mind
This was a small pilot trial and was not powered to assess effectiveness; actigraphy differences were nonsignificant.