针对神经发育疾病儿童睡眠问题的褪黑素：随机双盲遮蔽安慰剂对照研究

Abstract

Objective To assess the effectiveness and safety of melatonin in treating severe sleep problems in children with neurodevelopmental disorders.

Design 12 week double masked randomised placebo controlled phase III trial.

Setting 19 hospitals across England and Wales.

Participants 146 children aged 3 years to 15 years 8 months were randomised. They had a range of neurological and developmental disorders and a severe sleep problem that had not responded to a standardised sleep behaviour advice booklet provided to parents four to six weeks before randomisation. A sleep problem was defined as the child not falling asleep within one hour of lights out or having less than six hours’ continuous