Investigation ordered after 28 babies die in hospital experiment

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The Independent Online
MINISTERS HAVE ordered an inquiry into research at an NHS trust where an experimental treatment carried out on 122 premature babies resulted in the death or injury of 43 of them.

The inquiry, which addresses similar issues to those in the Bristol heart babies case, will focus on whether the experiment was allowed to go on too long and whether proper consent was obtained from the parents who allowed their babies to take part in the trial.

The experimental treatment at the North Staffordshire Hospital in Stoke- on-Trent involved the use of a new type of ventilator like a modern version of the iron lung to help the babies breathe. Between 1989 and 1993, 122 babies had the new treatment and 28 died and 15 suffered brain damage.

Some claim they were told it was the "safest, gentlest" treatment and they were being given the best care available. They say they were not told the treatment was experimental. The ventilators are no longer used for premature babies but they are still in use for older infants. The Independent has learned that Baroness Hayman, minister of health, ordered the inquiry last week and appointed Professor Rod Griffiths, regional director of public health for the West Midlands, to lead it.

The General Medical Council, the doctors' disciplinary body, is also examining a complaint from parents backed by a 1,600-page dossier.

A spokeswoman for the health department confirmed that Prof Griffiths had been asked to "undertake a review of the general framework for the approval and monitoring of clinical research projects at North Staffordshire NHS trust." Prof Griffiths has asked Dr Michael Harrison, former director of public health for the West Midlands, and Cynthia Nash, former general manager of the West Midlands public health directorate, both now of Midlands Health Consultancy Network, to carry out the review and report to him.

The Trust confirmed last night that the inquiry is focused on the ventilator study led by Prof David Southall, a consultant paediatrician who has attracted controversy over other studies including the covert video surveillance of parents suspected of child abuse. They were secretly filmed while their children were in hospital. Some were cases of Munchausen by proxy, the attention-seeking personality disorder. Between 1986 and 1994, that led to 34 successful criminal prosecutions. Prof Southall had been accused of being an agent provocateur and of false allegations. The inquiry into the North Staffordshire Trust was triggered when Llin Golding, Labour MP for Newcastle-under-Lyme, was approached by a family affected by the ventilator treatment. Carl and Debbie Henshall's daughter, Stacey, died on the machine in February 1992. Her sister, Sofie, born in November 1992, suffered brain damage and is permanently disabled. Ms Golding met the Henshalls then approached Baroness Hayman who set up the inquiry.

Ms Golding said: "I am not against research as long as the people involved know what is going on. The Henshalls felt they had not been informed about the experimental nature of the treatment.

"There is also a possibility that the research went on too long and should have been stopped sooner."

"I am not pre-judging the situation and I am not attacking Prof Southall. We need someone to look at children's issues with an open mind and he is trying to do things for children. The question is how far should he have gone?"

In a statement to The Independent last night the Trust said the ventilator study was approved by its research ethics committee and that it holds consent forms signed by all the patients involved.

All the babies were at high risk because of their prematurity and rates of death and disability among the 122 babies who received the experimental treatment were no different from those who received conventional treatment.

"There is no evidence to support the implication that any disability or death were a consequence of the study," it said.