Doctors are vindicated over baby experiment

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Indy Lifestyle Online

Two doctors accused of putting the lives of premature babies at risk in a trial of a new method of ventilation have been vindicated, eight years later, by a study which shows the babies have thrived.

David Southall and Martin Samuels, consultant paediatricians at the University Hospital of North Staffordshire, were suspended for two years from 1999 while their work was investigated. In the 1990s they experimented with a method of providing external respiratory support to babies with breathing difficulties that avoided intubating their lungs, which carried a risk of damage.

Called Continuous Negative Extrathoracic Pressure (CNEP) the method involved placing a box over the baby's chest and creating a vacuum that would help its lungs expand and draw in air.

The trial results were published in 1996. A government inquiry began in 1998 after some parents complained they had not known their babies were being treated with an experimental technique and had not given their consent.

The inquiry, chaired by Professor Rod Griffiths and published in 2000, was highly critical of aspects of the trial but was itself later criticised in a report and editorial in the British Medical Journal. Claims by parents that they were misled were investigated by the hospital, the GMC and the police, but were not substantiated.

Researchers from the Queen's Medical Centre in Nottingham report in The Lancet that the babies treated with CNEP in the original trial did no worse, and in some respects did better, than those given conventional treatment.

Now aged 9 to 15, the children treated with CNEP had "substantially higher" language and visual/spatial skills than those given conventional ventilation, the researchers say.

In a commentary on the findings, Professor Sir Alan Craft, president of the Royal College of Paediatrics, says Dr Southall's "pioneering" research has been subjected to "unprecedented scrutiny ... many lives have undoubtedly been saved by his research".

Dr Southall and Dr Samuels were the subject of a series of unrelated allegations in connection with their work in child abuse. They were cleared of all allegations and reinstated in 2001.

In an editorial, The Lancet says: "This drawn out process has been hugely damaging to the researchers and to the parents of the children enrolled."

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