The families decided to speak out after The Independent revealed that the Health minister Baroness Hayman has ordered an inquiry into the conduct of research at the North Staffordshire NHS Trust in response to concerns about a trial of a new type of ventilator to help the babies breathe. During the four-year study, from 1989 to 1993, 43 of 122 babies died or were brain-damaged.
Sharon Bradley, 30, said yesterday that she was taking legal action against the trust and had complained to the General Medical Council about the way the experiment was conducted. Her son Stephen, five, has severe learning difficulties, autistic traits and cannot talk. "I was not told anything about this being some sort of experiment. I was just persuaded that this was the best treatment for my son. I signed some things in the neonatal unit, but I had no idea this was a trial," she said.
Lisa and Paul Brerton said their life had been torn apart bythe death of their son Joshua in 1991 but they had not learnt he had been involved in an experiment until 1997. "We were hoodwinked into going along with the hospital. There are so many people you can blame ... all the doctors and hospital authorities, because they kept us in the dark so long."
Debbie and Carl Henshall, whose complaint to their local MP, Llin Golding, triggered the inquiry, said their consent form had been "manufactured". They had one daughter who died and one who was brain-damaged in 1992, but they only found out about the trial four years later. Mrs Henshall, who gave evidence to the inquiry on Tuesday, said: "I find that incredible. I know my way around a `prem' unit, having had six premature babies, but basically they fooled me. They fooled me not once but twice. I am angry about that."
It emerged yesterday that a leading expert on premature babies had declined to join the trial because he did not believe it would produce worthwhile results. Professor Richard Cook of Alder Hey hospital, Liverpool, a vice- president of the Royal College of Paediatrics, said: "I was not terribly impressed [with the ventilator]. I didn't think it was going to be the bee's knees. I thought there were other things better worth trialling."
Professor Cook said obtaining consent from parents at a time of intense stress, such as after the birth of a premature baby, presented enormous difficulties. In a study conducted by the National Perinatal Epidemiology Unit in five hospitals in which severely ill babies were placed on a heart- lung machine, the researchers interviewed the parents a year later to find out what they had understood.
"The researchers had taken enormous care about getting informed consent but were horrified to discover that the parents had completely misunderstood or failed to retain what it was about."
In the North Staffordshire trial, led by the consultant paediatrician Professor David Southall, the treatment involved placing premature babies who had difficulty breathing in a modern version of an iron lung using a technique known as CNEP (continuous negative extra corporeal pressure), instead of the conventional treatment of inserting a tube into their lungs and forcing in air.
Of 122 babies who had the experimental treatment, 28 died and 15 suffered brain damage. In a control group of 122 who had conventional treatment, 22 died and 10 suffered brain damage.
Despite the higher death rate among the experimental group (although the difference was not great enough to be statistically significant), the trust said yesterday that it was "an effective treatment in reducing the duration of oxygen therapy required ... in premature infants".
It added that the babies were "a very high risk group" and there was no evidence that any death or disability was a consequence of the study.
The British Medical Association said obtaining informed consent was "at the very heart of good medical practice".
A spokesman for North Staffordshire NHS Trust said last night: "We believe very firmly that our consent procedures went beyond the national guidelines of the time. I would accept that people in this situation [after a premature birth] are under huge stress and there may be a national issue of obtaining consent in these cases."Reuse content