The Reporter
Issue 496, 23 February 2004
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Neonatal trials – asking the right questions

Gaining consent from parents on behalf of their children for neonatal trials – where new treatments are tested on new-born, ill babies – is often asked for and given inappropriately, Leeds research has shown.

Dr Su Mason from the clinical trials and research unit interviewed 200 parents from nine European countries and found that in two-thirds of cases, the consent given for babies to participate in trials was ‘impaired’ according to best practice criteria drawn up by the unit.

“It’s a difficult area – new parents are naturally shocked and stunned, dealing with the reality of a very sick baby, and the mother might still be under the effects of the anaesthetic,” Dr Mason said.

“Yet they’re asked to take on board an experimental treatment and also the possibility that their child might not, in the end, receive it, under the trial’s randomisation process. Especially when babies are very ill and a quick decision is needed, the consent is often not ‘good’.”

Dr Mason is using the European findings to evaluate a consent process for a trial involving babies with asphyxia – reduced oxygen to the brain during birth – which can sometimes lead to brain damage. The trial is testing a new treatment to prevent brain damage which needs to begin within six hours of birth.

Under the trial’s consent process, parents are given two full explanations of the trial plus written details, before the consent form is signed. Then, if they agree to participate, the consultant will sit down with them the following day and explain the trial again, to ensure they fully understand the implications of their decision. They can change their mindat any stage.

Dr Mason will interview all parents and clinicians to assess the model’s effectiveness. “If it works, it could become the ‘gold standard’ for all trials in the UK,” she said.

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