Fluid Resuscitation Strategies in African Children

Fluid Expansion As Supportive Therapy (FEAST) in critically ill African children trial is underway in six hospitals across three African countries [6 ]. The trial examines three different fluid resuscitation strategies on 48 hour and 28 day survival. The design is pragmatic as children are enrolled on clinical criteria alone and it is being conducted in hospitals with facilities typical of many district hospitals across sub Saharan Africa. The main objective of the trial is to facilitate clinicians and policy makers working in sub-Saharan Africa in deciding the best strategy to adopt in managing children with febrile illness and features of shock.
For this late phase clinical trial of fluid resuscitation http://feast-trial.org/ or ISCTRN 69856593 we conducted a narrative review of international recommendations and guidelines, and of empirical literature, to inform our process of consent. Following a detailed review of international regulatory body requirements in these settings, we searched the academic literature through combining keywords in pubmed.org including "emergency", "consent", "clinical trial", "assent", "waiver", "paediatric", "community consultation "and "children". In particular, we considered two important practical and ethical aspects of the consent process: community consultation, and alternatives to prior full written consent among populations with diminished autonomy. Information from this review fed into consent discussions in trial planning meetings.