Newborn infection trial ‘will fail’ unless Government intervenes, experts warn
Two babies on average develop Group B Strep infection in the UK every day.
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A clinical trial to test pregnant women for Group B Strep (GBS) – the most common cause of life-threatening infection in newborn babies – will fail unless the Government intervenes, experts have warned.
Some 80 hospitals are needed for the trial to go ahead but only 32 have committed to it, with a deadline for registering of September.
The trial is being funded by the National Institute for Health Research (NIHR) and will look at whether testing women for Group B Strep reduces the risk of babies dying or suffering harm.
There seems to be little acknowledgement that this trial is heading towards failure
Now Dr Jane Plumb, chief executive of Group B Strep Support, who lost her son Theo to the infection, is calling on the Government and NHS England to intervene to make sure the trial goes ahead.
She said: “The reality is that unless a further 48 hospitals sign up for this trial, then it will fail.
“The Government is waiting for the results from this trial to determine whether to test pregnant women for Group B Strep.
“Yet there seems to be little acknowledgement that this trial is heading towards failure.
“We need more hospitals on board and we need to make sure that the investment in this trial is not wasted.
“This is about saving the lives of babies, and it really is now or never.”
According to the charity, several local MPs have contacted hospitals themselves, after being urged to do so by the public.
Dr Plumb said: “We’re all interested in the results, but unless enough hospitals take part, the trial will fail.
“What is the Government and the NHS doing to ensure this trial is a success?”
According to the charity, the excess treatment cost threshold – the amount a trust has to put into research before they start getting reimbursed – has also been reduced, meaning cost should not be stopping trusts from signing up.
Data shows that two babies on average develop GBS infection in the UK every day, leading to one death a week and one baby left with long-term disabilities.
Many other countries, including the US, already screen for the infection.
The new trial – called GBS3 – is being led by researchers at the University of Nottingham.
It will look at whether testing reduces the risk of infection in newborn babies compared to the current strategy in place in the UK.
The current strategy is to offer antibiotics during labour to women who are considered at increased risk of their baby developing a Group B Strep infection.
Two different tests will be examined – a lab-based test three to five weeks before a woman’s due date and a bedside test at the start of labour.
This trial and the results are vital in stemming the rising tide of GBS infection in UK babies
Dr Carol Baker, whose work led to universal GBS testing being introduced in the US, said: “The US introduced routine testing for Group B Strep for all pregnant women 20 years ago, and the rates of early-onset Group B Strep infection in babies subsequently fell by over 80%.
“Other countries have seen similar declines but UK rates are increasing.
“This trial and the results are vital in stemming the rising tide of GBS infection in UK babies.”
Olympic runner Iwan Thomas, whose first child, Teddy, feel ill with GBS, said: “Watching Teddy covered in tubes and fighting for his life in intensive care was by far the worst experience of my life.
“Fortunately, Teddy’s made a great recovery from his Group B Strep infection, but I know there are those less fortunate whose children have died or survived with life-changing disabilities.
“That’s why I’m so passionate about the GBS3 trial succeeding, so other families don’t have to go through what I and so many others have.
“It’s outrageous that in 2022 babies are getting sick and dying from a preventable infection.”
A Department of Health and Social Care spokeswoman said: “Protecting pregnant women and their babies from disease is an absolute priority as we tackle disparities in maternity care across the country.
“We are working closely with NHS England and the NIHR to encourage participation in this trial, including reducing the cost to NHS trusts to take part.
“The NIHR continues to monitor recruitment of trusts into this important trial.”
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