Government sets up inquiry into ventilation trial

An inquiry has begun into research conducted at the North Staffordshire Hospital after parents alleged that they were misled into consenting to experimental treatment for their premature babies.

A new type of ventilator was tested between 1989and 1993on 122babies who had breathing difficulties in a randomised controlled trial of a technique called continuous negative extrathoracic pressure (Pediatrics 1996;98:1154-60). Of these infants, 28died and 15sustained brain damage. In the control group, in which conventional treatment was given to the same total number of babies, 22died and 10sustained brain damage. The authors of the study and the hospital have claimed that the differences are “not statistically significant.”

Several families have complained that they were unaware of the experimental nature of the treatment. Two daughters of Carl and Debbie Henshall, from Stoke on Trent, received the experimental treatment. Stacey died while on a ventilator in February 1992; 10months later the second child, Sofie, was found to have brain damage. The couple say they only found out about the trial four years later. They say a doctor whom they consulted about Sofie's developmental problems told them the ventilation treatment she had undergone at North Staffordshire Hospital had been experimental.

“They fooled me not once but twice, and I”m angry about that,” Mrs Henshall said. She and her husband say they were told that the new treatment was safer and of proved effectiveness. When Stacey was born prematurely, Mr Henshall signed a consent form after “a clipboard was pushed under his nose,” according to his wife. “Carl presumed this was normal procedure. Carl put his trust in the doctors.”

The NHS hospital trust in Stoke on Trent says that it has signed consent forms for every child included in the study, which was led by consultant paediatrician Professor David Southall and approved by the local research ethics committee.

Eighteen parents of babies involved in the study have lodged complaints with the General Medical Council. An inquiry ordered by Baroness Hayman, the health minister, and headed by Professor Rod Griffiths, regional director of public health for the West Midlands, began taking evidence last week. The inquiry was set up after the Henshalls took their complaint to their local MP for Newcastle under Lyme, Llin Golding, last year.

Dr Simon Newell, consultant in neonatal medicine at St James's Hospital, Leeds, went to see how continuous negative extrathoracic pressure was working at Stoke on Trent in 1991.”I decided to await the outcome of the study before deciding whether we should bring it in at Birmingham, where I was then lecturing in neonatal medicine. I think it was a well conducted study and it addressed a reasonable hypothesis. The question was whether the benefit was sufficient to compensate for the practical difficulties of using it with babies in these circumstances. In common with everyone else, I decided it wasn't.” That method of ventilation is no longer used for neonates but is still used for older children in a few units.