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X-files of the Guinea Pig Babies; 28 CHILDREN DIED AS THIS MAN EXPERIMENTED WITH A NEW FORM OF TREATMENT. HE TOLD THEIR PARENTS IT WAS 'KINDER AND GENTLER'.

TWENTY-EIGHT babies died after suffering appalling injuries in controversial experiments carried out by one of Britain's top consultants, the Sunday Mirror can reveal today.

The medical trials involved a total of 121 babies - most born prematurely - and were sanctioned by two hospitals and their ethics committees. They left at least 15 more children permanently brain damaged.

All the babies were suffering from breathing difficulties. Instead of being put into traditional cot-like open incubators, they were placed in experimental ventilation "tanks".

Many parents were told the treatment would be "kinder and gentler" on their children. Others say they were not informed of the decision to put their babies through the tests. And some even claim their signatures were forged on consent forms, although no individual has been formally accused.

The trials were led by Professor David Southall. He and another consultant, Martin Samuel, have been suspended after a damning Department of Health report and the General Medical Council is investigating.

Professor Southall, 52, has defended the experiments, insisting they were as safe as conventional treatment and caused no harm.

However, official research papers in our possession reveal the disturbing nature of the trials carried out at London's Queen Charlotte Hospital and the North Staffordshire Hospital in Stoke-on-Trent.

They tell in detail how some babies suffered serious brain damage, hypothermia and horrific neck scars.

The documents were written by two of Professor Southall's most senior researchers responsible for the day-to-day recording of the experiments which took place in the late 1980s and early 90s.

The reports have been lodged in the dusty archives of libraries in Stoke and Manchester since 1995.

Couched in often obscure medical jargon, they tell of the effects of the trials which involved a new type of ventilator chamber using a technique known as Continuous Negative Extrathoracic Pressure (CNEP).

The babies were placed in an airtight plastic container with their necks outside held in place by a tight rubber seal. Air was then sucked out of the chamber creating a vacuum around the infant's chest.

The idea was to relieve pressure on the babies' lungs, helping them to breathe more freely. But one researcher's document admits that early studies using a similar technique showed serious problems. These included:

-The "garrotting effect" caused by the tight neck seal.

-Hypothermia after air was sucked out of the chamber

-And loss of blood flow to the head leading to brain injuries.

The reports go on for hundreds of pages detailing the daily recordings, including graphs, of the 121 babies in the CNEP trials.

Behind the dry statistics and convoluted medical language lies a terrible human tragedy.

Heartbroken parents have told the Sunday Mirror of their anguish at being confronted with the awful truth that their precious children had been used as guinea pigs in the experimental programme.

Many say they were unaware their vulnerable babies were taking part in an experimental procedure that in the past had been criticised

It was only when the incidents of deaths and brain damage among children on the CNEP wards began to mount that parents became suspicious.

Their suspicions turned into outrage when some parents said they had not even been asked if their child could take part in the experiments. Others claimed their signatures on consent forms had been forged. Babies suffering breathing difficulties are normally treated in a cot-type open incubator. Tubes are introduced into their mouth and nose allowing oxygen into their lungs. The treatment is usually favoured because it allows easy access to the child and mothers are able to bond with them.

However, Professor Southall was keen to pioneer the CNEP approach - and the research documents list some of the results.

In one section the researcher reports "an increased incidence of hydrocephalus (water on the brain) in infants...due to compression of the jugular".

In the other document, the researcher tells of a number of infants developing "significant neck trauma" while in the CNEP tank. He writes: "The most severe case occurred in a 25-week triplet. Following the removal of the neck seal, the neck was noted to have a circumferential ring of yellow necrotic skin."

He provides shocking post-mortem photographs of the infant bearing terrible scars.

Difficulties in keeping the babies warm are also recorded. The researcher says: "The most severe case of temperature instability occurred in a 26-week gestation twin. The infant's temperature dropped to 33C following transfer into the negative pressure chamber."

According to the Department of Health report, the CNEP scandal was the result of poor training, weak controls and gaps in supervision.

It blamed vague guidelines, doctors going it alone and lack of scrutiny by ethics committees - and identified weaknesses in proceedings handled by Professor Southall and Dr Samuels.

Professor Southall, who was last year awarded an OBE for his services to children in Bosnia, is currently suspended from his job as three General Medical Council inquiries are carried out into his work.

One is focussing on his decision to set up covert video equipment to record mothers with their children in a special ward at the Royal Staffordshire Hospital.

He wanted to show that babies experiencing mysterious medical problems were in fact being harmed by their parents.

As a result a number of children were removed from their parents who were accused of the attention-seeking disorder, Munchausen Syndrome by Proxy. Although some parents were later successfully prosecuted, others were found to be entirely innocent.

Another GMC case involves experiments where infants were starved of oxygen. The tests were designed to see if babies who had been on air flights were more susceptible to cot deaths.

The professor, who lives with his wife Jean and four children in Leek, Staffs, has seen a pounds 150,000 lottery grant for his charity, Child Advocacy International, `put on hold.

But in a defiant statement he has declared: "Have I been intimidated by events? No. Would I become involved in child protection if I had my time again? Unequivocally, yes.

"And I don't imagine for a moment that the battle is anywhere near done."
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Title Annotation:Features
Author:Rimmer, Alan
Publication:Sunday Mirror (London, England)
Date:Jul 9, 2000
Words:1006
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