Understanding sleep problems in children with prenatal alcohol exposure: implications for a clinical trial

Abstract

Introduction: There is growing recognition that a significant number of children with fetal alcohol spectrum disorder (FASD) experience marked difficulties with regulating their sleep, in part due to abnormal circadian rhythms. Melatonin has been proposed as a potential pharmacological treatment but has not been evaluated in this population.

Design and Methods: We have designed a randomised double-blind, cross-over study of melatonin and placebo in young children aged 5-12 years. Following a four-week sleep hygiene intervention, children who fail to show improvement are eligible to enter the melatonin/placebo or placebo/melatonin phase of the trial.

Key Findings: The trial has commenced and recruitment and retention will be reported. Adherence to the treatment regime has been good. Qualitative interviews from carers post trial indicate enduring difficulties pre-trial in children's sleep behaviours, and some challenges in adhering to a complex trial process that requires recording of sleep using sleep diaries and wearing of actigraphy watches.

Discussion and Conclusions: Preliminary findings suggest that this trial is feasible. Recruitment of children meeting study inclusion criteria is challenging but retention to date suggests that this trial will be able to recruit an adequate sample size.

Implications for Practice: Children with FASD are routinely prescribed melatonin and other medications to assist with sleep. There has been no systematic evaluation of this and thus this trial has an important role in evaluating the efficacy of this treatment. The link between sleep and executive functioning, a key area of challenge for children with FASD, is critical as poor sleep may be contributing to their social, academic and functioning difficulties.