Parents of the babies claim they were not informed of the risks of allowing their children to take part in the trial at North Staffordshire hospital between 1989 and 1993. In all, 122 babies participated, of whom 28 died and 15 suffered brain damage.
The parents claim they found out about the experimental nature of the study only after the researchers wrote up their findings in a medical journal. Now they are banding together to press for compensation and a full inquiry, claiming their children's deaths or injuries were caused by the treatment and that, although they consented, they were not made aware of the dangers.
In the study, babies with breathing problems were put on a "continuous negative extrathoracic pressure" (CNEP) respirator. Their whole body, below the neck, was placed in a low-pressure chamber to make their lungs expand continuously. Premature babies with failing lungs are normally treated by "positive pressure" ventilation, involving the insertion of a tube in the mouth, to aid breathing.
A seal was fitted around the babies' necks. In the trial, two babies' necks were injured by the seal. The babies later died.
CNEP research was carried out at North Staffordshire hospital, Stoke- on-Trent, and Queen Charlotte's, London. At North Staffordshire, the trial lasted 43 months and at Queen Charlotte's 15 months.
The complaints received so far relate only to North Staffordshire, where a local solicitor, James Evans, is co-ordinating the parents' action group.
Among the parents are Debbie and Carl Henshall from Stoke. They are suing North Staffordshire Health Authority for negligence over the brain damage caused to their daughter, Sofie, now aged five. They also plan to sue over the death of another daughter, Stacey, who underwent the same treatment.
Sofie suffered cerebral palsy and is now severely handicapped. "We were not made aware that Sofie's treatment was part of a trial," said Mr Henshall.
To date, nine families have contacted Mr Evans. They say the first they knew of their children having been used as "guinea-pigs" in a process not previously tried on such young babies was when an American journal published an account of the study last December. The article, by the researchers at North Staffordshire, led by Professor David Southall and Dr Martin Samuels, made plain the dangerous nature of the trial.
"The higher frequency of cranial ultrasound abnormalities [brain damage] in the CNEP-treated infants was of concern," the researchers wrote. "CNEP may affect the cerebral circulation in one of two ways... The net effect of these alterations in cerebral blood flow is unknown."
None of the risks was spelt out to the parents, who say they signed consent forms and were shown an information sheet, but this claimed that CNEP was safe. "Although the technique has been shown to be safe and effective, we now need to find out whether it is better than the usual treatment," it said.
"I honestly did not know Sofie was going into a research trial," said Mrs Henshall. "I was told this was a new, proven ventilator from America which would soon become the normal treatment for premature babies in this country. Now I know this wasn't true."
Parents were asked for their consent at a time of great emotional stress. Mrs Henshall gave her consent when Sofie was between two and four hours old, when "I was still under the effects of morphine in the recovery room following a caesarean.
"I believe that Sofie was being slowly asphyxiated by the pressure of the ventilator's neck seal and this was the cause of the cerebral palsy," says Mrs Henshall.
Mr Evans said: "More than 100 babies underwent treatment with this machine. Current inquiries may be only the tip of the iceberg." Dr Andrew Spencer, clinical director of child health at North Staffordshire hospital, is handling the hospital's case. He said "it was a clinical trial the babies were taking part in - which was explained to the parents at the time. When people are in a stressful situation, they often find it difficult to remember the details explained to them."Reuse content