Deaths of 16 babies in health trial 'inevitable'

SIXTEEN brain-damaged babies who died after they were given Epsom salts in an international medical trial would probably not have survived anyway, according to a report into the clinical research, which was based in Leeds.

But a serious error that led to some babies receiving a double dose of magnesium sulphate has prompted the Medical Research Council to tighten the pharmaceutical procedures surrounding such trials. "This was an important experiment aimed at improving the treatment of brain-damaged infants," said David Ansbro, who chaired the independent investigation into the trial.

"Unfortunately, the trial had to be suspended when an error over the dosage of the magnesium sulphate came to light."

A double dose was administered to at least some of the babies because of medical confusion over the varying strengths in which the compound is available.

A total of 28 babies in eight countries were given the magnesium sulphate mixture in an injected form two hours after their birth.

The same number of dangerously asphyxiated babies also received a placebo saline injection to create a control group.

The Randomised Asphyxia Study Trial was financed by the Medical Research Council and the NHS Executive and it was set up and run by Malcolm Levene, professor of paediatrics at Leeds University.

The scientific team involved hoped their work would confirm the beneficial effects of prescribing Epsom salts to the one in 1,000 new-born infants who are seriously starved of oxygen during their journey through the birth canal.

Such babies frequently go on to develop life-threatening complications, including severe brain damage. A quarter of babies who suffer oxygen deprivation die and a quarter survive with serious handicaps.

Thirty-nine babies at 15 hospitals in Britain, including Leeds General Infirmary and St James's Hospital in Leeds, were involved in the experiment when their mothers signed a consent form at the time of birth.

But 10 months into the trial, in September 1996, Professor Levene cancelled the project because of a report that babies in Sweden and Finland had been given twice the correct dose of magnesium sulphate.

The independent investigation into the trial was set up by the Northern and Yorkshire Health Executive after the double dose allegations were made.

As part of its recommendations, released earlier this summer, the report called for greater clarity in prescription details.