This follows research led by Saint Mary’s Hospital, part of Manchester University NHS Foundation Trust (MFT), The University of Manchester and 91ֱ��-based firm genedrive Plc on the Pharmacogenetics to Avoid Loss of Hearing (PALOH) study. Together with 91ֱ�� based genedrive plc, they developed the pioneering, rapid bedside genetic test which was piloted at MFT in 2022.

Using a cheek swab, the test can identify in 26 minutes whether a critically ill baby admitted to intensive care has a gene change that could result in permanent hearing loss if they are treated with a common emergency antibiotic, Gentamicin.

While Gentamicin is used to safely treat approximately 100,000 babies a year, one in 500 babies carry the gene change that can lead to permanent hearing loss when given the drug.

The new test means that babies found to have the genetic variant can be given an alternative antibiotic within the ‘golden hour’ which could save the hearing of 200 babies in England every year.

PALOH study lead, Professor Bill Newman, Consultant in Genomic Medicine at MFT and Professor of Translational Genomic Medicine at The University of Manchester, said: “We are delighted that NICE has conditionally recommended the use of the test, which will be used in routine clinical practice in maternity settings across the country.

“We piloted the device at MFT in 2020 for 11-months and during that period we tested 750 babies and detected the genetic variant in three babies. Since being rolled out within our services at Saint Mary’s Hospital in November 2022, we have prevented the hearing loss of one baby.

“Our experience of using this test has been very positive. It’s straight-forward, non-invasive and will have a huge impact on our patients’ lives. The test will make a real difference, helping to ensure babies are not going to lose their hearing for a preventable reason.”

The system was developed in close collaboration with Professor Newman, Associate Lead, Hearing Health Genomic Solutions at National Institute for Health and Care Research (NIHR) 91ֱ�� Biomedical Research Centre (BRC) and his team at 91ֱ�� BRC.

The new swab test technique replaces a test that traditionally took several days and is the first use of a rapid point of care genetic test in acute neonatal care.

Evidence presented to the independent NICE committee from the PALOH study carried out in 91ֱ�� and Liverpool showed no statistically significant difference between the time to antibiotic treatment between standard care and when using the genedrive device. This suggests that introducing the test will not delay the time it takes to administer antibiotics.

Once in use, the NHS will collect further evidence to ensure the test can be put in place in a variety of different maternity settings. This additional evidence will also be scrutinised by the independent NICE committee as part of the full assessment.

David Budd, CEO of genedrive plc, said: We look forward to receiving the final NICE report and recommendations for the world’s first rapid point-of-care genetic test used to influence neonatal management in an acute care setting.”

Around 1,249 babies are born in England and Wales with the variant each year. At the moment, babies treated with gentamicin who go deaf are only discovered to have the genetic variant with DNA testing afterwards.

The estimated cost of treating hearing loss with a bilateral cochlear implant is around £65,000 in the first year.

Mark Chapman, interim director of Medical Technology at NICE, said: “Until now there has not been a test quick enough to ensure that newborn babies with a bacterial infection and the variant gene are treated with an appropriate antibiotic. Having this test available to NHS staff can avoid the risk of hearing loss in babies with the variant who need treatment with antibiotics. Hearing loss has a substantial impact on the quality of life of the baby and their family.

“The costs associated with hearing loss to the NHS are high, so driving an innovation like genedrive into the hands of health and care professionals to enable best practice can also ensure that we balance the best care with value for money, delivering both for individuals and society as a whole.”

According to a study led by and researchers – in collaboration with –  almost three quarters of the stillbirths officially certified as being of, “unknown cause of death,” in fact had an identifiable cause.

Proper understanding of the causes of stillbirth play an important role in determining how care is provided to women and babies in the future. Therefore, to inform this, it is vital reporting processes on MCS are accurate.

Of 540 certified unexplained stillbirths studied, only 119 remained unexplained following the analysis: the majority were re-designated as either fetal growth restriction (FGR; 195 deaths), or placental insufficiency (184 deaths).

Overall, FGR, at 306 cases, was the leading primary cause of death after review, yet only 53 of the cases were originally attributed correctly.

The paper is published in International Journal of Epidemiology today (insert date).

Though its causes are still unclear, FGR predominantly occurs when the placenta is not working well enough to provide a baby with the nutrients to grow normally, and is linked to an increased risk of complications in pregnancy and stillbirth.

Most babies that are born smaller than expected will grow up healthy, but some will have high blood pressure, diabetes or heart disease in adulthood.

Over 80 per cent of MCS in the study contained errors; 55.9 per cent had a major error that would alter their interpretation.

Other findings included:

• The inaccuracies occurred irrespective of geographical location
• Hospitals in regions where certificate audits had previously been carried out were less likely to contain major errors, possibly due to increased error awareness.

The team gathered data from 76 UK obstetric units, examining Medical Certificates of Stillbirth issued from 1 January 2018 to December 31 2018.

Systematic case note reviews of stillbirths were carried out by the – a network of non-consultant grade Obstetrics and Gynaecology doctors who work jointly on large audit and research projects..

After review, UKARCOG doctors generated ideal “mock” certificates which were then compared to the actual document issued.

Lead author Dr Lucy Higgins, a Senior Lecturer in Obstetrics at The University of Manchester and Consultant Obstetrician at MFT’s , said: “This study demonstrates widespread major errors in the way Medical Certificates of Stillbirth are completed across the UK.

“Once redesignated, fetal growth restriction became the leading cause of death in these stillborn babies.

“The study did not examine the standard of care received prior to the baby’s death, simply whether the data reported on the Medical Certificate of Stillbirth accurately reflected the facts surrounding the baby’s death.

“That is why we argue these documents should only be completed following a structured case note review, with particular attention to fetal growth trajectory.”

Co-author Professor Alex Heazell, Director of the at The University of Manchester and Consultant Obstetrician at Saint Mary’s Hospital, said: “Data from Medical Certificates of Stillbirth inform healthcare service strategy, funding, research and public health initiatives. It is imperative to identify preventable stillbirths to aid future strategies to reduce deaths."

Kath Abrahams, Tommy’s Chief Executive, says: “With every baby loss, devastated parents most commonly ask ‘why?’. They want to know why their baby died and what could be done in future to reduce the risk of it happening again.

“Without an accurate cause of death, parents are left without an explanation and researchers working to find the causes of stillbirth and how to prevent it are left without the information they need to inform their work. It is not always possible to know why a stillbirth happened, but this review shows that ‘unexplained’ should not be the norm. Accuracy alongside compassion should be prioritised when certifying stillbirth.”

Sands supports anyone affected by the death of a baby. Sands’ free Helpline is available on 0808 164 3332 10am to 3pm Monday to Friday and 6-9pm Tuesday and Thursday evenings. You can also email helpline@sands.org.uk for support.  

The study, published in Biology of Reproduction, is the first to compare the biological effect of Bisphenol A (BPA) -  found in canned food, plastic bottles, food containers, toys, and medical equipment - on male and female placental tissue-  a powerful indicator of an unborn baby’s health.

Levels of Estrogen Related Receptor Gamma (ESSRG), an important gene in human placenta and a receptor for BPA, was half as abundant in male than in female placental tissue after treating with BPA, they found.

Though its causes are still unclear, FGR occurs when the placenta is not working well enough to provide a baby with the nutrients to grow normally, and is linked to an increased risk of complications in pregnancy.

Babies born with FGR are also at heightened risk of high blood pressure, coronary artery disease, type 2 diabetes and thyroid disease in later life.

Most babies that are smaller than expected will grow up healthy, however according to Tommy’s, up to 10% of pregnancies will be affected by FGR and need close monitoring during pregnancy.

The study was funded by Tommy’s, The University of Manchester and the China Scholarship Council.

Scientists already know that more than 90% of humans have BPA in their blood and urine and that exposure during pregnancy can be associated with low fetal weight, particularly in boys.

Though an association between FGR and BPA exposure has been identified in epidemiological studies, the study is the first to discover a potential biological mechanism.

The scientists mimicked environmental BPA levels in 18 placental samples from heathy pregnancies: 9 were male and 9 were female. They then cultured the samples for up to 48 hours and measured how the levels of ESRRG and its downstream genes changed.

The median mRNA and protein levels of ESRRG were significantly decreased by 38% and 28% respectively in the male placental tissue treated with 1 nanomole of BPA for 48 hours.

The median mRNA levels of ESRRG’s downstream genes were significantly decreased by 66% in the male placental tissue treated with a 1 nanomole of BPA for 48 hours.

At higher BPA levels of 1 micromole, median mRNA levels of ESRRG were reduced by 39% in male placental tissue after 48 hours. However, it increased the median of mRNA and protein levels by 32% and 24% respectively in the female placental tissue after 24 hours of culture.

Lead author Zhiyong Zou, a PHD researcher at The University of Manchester said: “For the first time we identify a possible biological mechanism which could explain why Bisphenol A exposure in mothers is linked to fetal growth restriction in some baby boys.

“Our study of placenta suggest that this abundant chemical found in plastics binds with a gene called ESRRG to interrupt its signalling pathways in male human placentas. That could affect the functioning of a baby’s placenta and consequently, it’s development in the womb .

”It also opens up the possibility of a therapeutic drug target.”

Principle Investigator Professor Alexander Heazell from The University of Manchester said: “The biology of a placenta can tell us much about the health of a baby.

“So this exciting discovery is a milestone in our understanding of fetal growth restriction following exposure to BPA and why it seems to be more prevalent in baby boys.

“However, there is some way to go before we fully understand its implications, in particular whether pregnant women should avoid BPA-containing product.”

Co-author Dr Karen Forbes from The University of Leeds and honorary researcher at The University of Manchester said: “FGR is linked to many factors, such as problems in pregnancy like preeclampsia, so though valuable, this discovery will not be a silver bullet.

“And it’s important to stress, that though most of us have Bisphenol A in our blood, there is no evidence to suggest that it has implications on the health of most people.

“Nevertheless, a simple blood test measuring levels of BPA and ESRRG in high risk patients maybe prove may one day prove to be a valuable intervention.”

The paper sex-specific effects of Bisphenol A on the signalling pathway of ESRRG in the human placenta is published in Biology of Reproduction.

The devastating effects of a rare condition affecting new-born babies will be far worse if diagnosis and treatment are delayed.

Up to half of all babies born with congenital hyperinsulinism (CHI) - a disease that causes extremely low blood sugar - suffer from life-long disability.

But with more prompt detection and individualised management, patient outcomes are much more favourable, report the researchers in a new review published in Diabetic Medicine.

CHI - also coined the clinical opposite of diabetes - is the most common cause of persistently low blood sugar (hypoglycaemia) in early childhood.

Although generally rare, affecting just 1 in 50,000 children in the UK, CHI can be as common as cystic fibrosis (1 in 2,500) in some countries such as Saudi Arabia.

The research team from 91ֱ�� reviewed current therapies and outcomes of children and young adults with hypoglycaemia brought about by CHI.

According to the scientists, a hypoglycaemic episode - when blood sugar (glucose) concentration dips below 3.0 mmol/L - is harmful for the survival of nerve cells.

Treatment typically aims to make sure blood glucose does not drop lower than 3.3 to 3.8 mmol/L.

“Symptoms of low blood glucose in babies are very distressing. Babies are floppy, don’t feed very well and have a pale or bluish skin colour. It is really important that hypoglycaemia is recognised by parents and clinicians, and that it is treated quickly to prevent brain injury,” explained Doctor Karen Cosgrove, from The University of Manchester, who was involved in the study.

Scientists now understand that there is a critical window after birth in which an adequate energy supply is required for the correct development of the brain.

And that explains why new-borns are more prone to suffering from the life-long effects of low blood glucose than adults.

“Our initial data suggest that with earlier referral, the frequency of cases with adverse neurological development is reducing” explains Professor Mark Dunne from The University of Manchester and lead author on the study.

In healthy people, insulin brings down blood glucose when its concentration rises.

When an infant with CHI experiences a hypo - a hypoglycaemic episode - it is a result of their bodies releasing too much insulin.

This is unlike diabetes, where a hypo often occurs due to a mismatch between the patient’s glucose concentration and their medication.

Any form of hypo can be dangerous as glucose fuels vital organs in the body, especially the brain.

Mild symptoms such as the infant appearing drowsy or struggling to keep warm can quickly escalate into life-threatening seizures or comas if left untreated.

Repeated episodes of hypoglycaemia without prompt treatment may permanently affect the learning, memory and behaviour of a child.

Dr Karen Cosgrove added: “Providing early and individualised medical treatment for these babies is very important if we are to safeguard their health and improve their quality of life in the long-term.”

This review paper is available

To find out more about the impact that CHI has on families around the UK, visit For more information on one of the specialised UK services that treats CHI patients, visit