Public urged to take part in consultation on life-saving test to identify heart defects in newborns
The public is being urged to take part in a consultation over a national recommendation not to roll out a life-saving test to identify newborn babies with critical congenital heart defects pioneered by experts in Birmingham.
Pulse oximetry is a simple, non-invasive test, which measures oxygen in the blood. The PulseOx study in 2011, led by University of Birmingham Professor of Neonatal Medicine and Honorary Consultant Neonatologist at Birmingham Women’s Hospital Andrew Ewer, found the test successfully identified serious heart conditions in newborn babies.
It was hoped pulse oximetry screening would become an additional test in the Newborn and Infant Physical Exam (NIPE), which every newborn baby undergoes. However, the UK’s National Screening Committee has recommended against the move. The Committee is now running a public consultation, which closes on August 9th 2019, as to whether the evidence they have considered is sufficient to support the decision to approve the recommendation.
The Committee said it does not want to recommend pulse oximetry screening for all babies as there is currently insufficient evidence to suggest that there is a greater benefit to babies and there are “harms” associated with the test. The harms the Committee outlined were parental anxiety, overdiagnosis, false positives and false negatives. They also said babies who test positive will need a longer stay in hospital and admittance to a neonatal unit.
Now Professor Ewer and three fellow consultant neonatologists from around the UK have outlined in a paper published in The Lancet (i) the reasons why they think the Committee has made the wrong recommendation.
Professor Ewer said: “Between 1,400 and 2,100 babies in the UK are born with a critical congenital heart defect each year. With these conditions the baby can look apparently healthy after birth but suddenly present with life-threatening collapse and many may die as a result.
“Less than half of these conditions are diagnosed before birth and routine examinations miss up to one third. Early identification significantly improves the outcome for these babies and in many cases can be life-saving. The same is true for the early identification of serious infections and breathing problems.
“Currently pulse oximetry screening in the UK is a postcode lottery and less than half of the babies born are offered this test depending on the hospital of birth.
“This is despite there being very strong global evidence that pulse oximetry screening is beneficial and cost-effective and that potential harms are not serious or common.
“We urge parents, patients, and health professional to voice their views on this important consultation.”
Pulse oximetry screening is a simple test performed on babies before discharge from hospital. It takes less than five minutes and is completely harmless and painless. The test sees a small probe wrapped around the baby’s hand and foot and connected to a small, handheld machine that measures the baby’s oxygen levels by shining a light through the skin.
Birmingham Women’s Hospital, part of Birmingham Women’s and Children’s NHS Foundation Trust and home to the largest fetal medicine unit outside of London, has been routinely screening babies with pulse oximetry since 2009.
In the PulseOx study, 165 babies with potentially serious illness were identified after performing the test, helping save lives and reduce the risk of long-term impacts on health.
Following publication of the results of the study, funded by the National Institute for Health Research, the simple test - which offers instant results - has been recommended across the United States, Norway, Germany, Spain and many other countries. Currently in the UK, 40% of all maternity units are using the test.
A Cochrane review (i) of pulse oximetry screening, which was published by Professor Ewer’s team last year, included data from almost half a million screened babies and a European consensus statement led by Professor Ewer recommended Europe-wide adoption.
Meanwhile several children’s heart charities, including the Children’s Heart Federation, Tiny Tickers and Little Hearts Matter, have been running campaigns advocating pulse oximetry screening.
Jon Arnold, Chief Executive of Tiny Tickers, said: “At Tiny Tickers, we're responding to clinical demand for the test and doing something practical to help. I’m proud to say we’ve already funded 96 machines across the UK.
“Every day, hundreds of babies born are being tested with machines we’ve placed, and more and more hospitals are starting to offer pulse oximetry screening. We know this test makes a difference - hospitals have been in touch to say babies’ heart conditions have been picked up after tests with the machines we funded.
“That's great, but so many babies still aren't being testing. We passionately believe pulse oximetry should become a mandatory part of newborn screening - meaning every baby is offered the test. But the NHS is recommending this doesn't happen.
“That's why we're urging you to have your say. If you agree with us, the public consultation is your chance to tell the NHS how important you think it is that every newborn has a chance to have the test that could help save their life.”
Views can be submitted to the National Screening Committee by emailing firstname.lastname@example.org by Friday, 9th August 2019.
CASE STUDY: Lyla’s Story
Born on September 2nd 2015, Lyla Parry’s heart condition was finally detected when she was 11 days old and only when she was in heart failure. If pulse oximetry screening had been part of the routine newborn checks her condition could have been detected sooner. This is her story, as told by her mum, Janine Parry, of Northampton:
I had gestational diabetes throughout my pregnancy with Lyla, my second child, so I was closely monitored because of the associated risks and I had fortnightly scans. Despite Lyla not moving very much nothing untoward was detected during her scans.
Lyla was born by cesarean section and she passed all the newborn tests, which did not include pulse oximetry screening, with flying colours.
However, during our first night together in hospital I began to have concerns. She wouldn’t wake to feed and, despite stripping her down and changing her nappy, she wouldn’t rouse from sleep. This was a clear indication that something wasn’t right but, nonetheless, the following day we were discharged by a paediatric midwife.
At home Lyla was very sleepy and panting. I felt deeply unsettled and anxious, but when I raised my concerns to the visiting midwives, I was told it was normal.
She stopped breastfeeding and appeared to have a blue tinge on her forehead and upper lip. The days passed and my concern began to escalate.
Then, on day 11, she projectile vomited two of her feeds. I booked a GP appointment for the following day, assuming it was an allergy - her sister was lactose intolerant.
Our doctor checked Lyla over and listened to her heart, then her legs. He said he believed she had a heart defect called Coarctication of the Aorta, a condition he had diagnosed twice before, and that she needed to go to the local hospital in Northampton immediately.
Still oblivious to the seriousness of Lyla’s condition, we went straight to the children’s ward. After just 30 minutes of observation by the medical team, we were given the devastating news that our baby was in heart failure.
Lyla’s heart scan showed that she had a severe narrowing of the aorta. Her treatment would need to be started immediately. As we were transferring to the high dependency unit, Lyla stopped breathing twice and had to be resuscitated.
I couldn’t believe what I was seeing. In the space of a few hours, my world had fallen apart – I thought we had lost my baby girl.
A second scan showed that the narrowing was getting worse by the hour and Lyla would need to be transferred to the nearest available intensive care at The Evelina Hospital in London. All I could do was pray that she would get through the journey.
Arriving at the Evelina at 2.20am on 15th September, the medical team stablised her and, by 7am, they told us that Lyla would require open heart surgery and bypass.
Her condition was urgent and the surgery would need to happen that afternoon. By this point, I couldn’t stop crying. Looking back on that day, it is all a blur. All I wanted was somebody to tell me that she would be ok, but of course, nobody could.
With Lyla in surgery, my husband and I tried to pass the time. We went for a walk along the Thames. Everywhere I looked people seemed so carefree.
By 6.30pm, Lyla was out and the surgery had gone well. Seeing my beautiful little girl covered in wires and tubes was desperately hard, but I was elated that she had got through the surgery.
It wasn’t an easy recovery, she had breathing issues and had to be put back on oxygen when her condition took a turn for the worse. She was diagnosed with a vocal cord palsy as a result of the operation, a common complication which meant feeding had to be monitored. And she was diagnosed with laryngomalacia, unconnected to her heart condition, but it too affected her breathing.
Thankfully, despite these complications, she recovered well and we were able to take her home on 25th September, which was also my birthday therefore the best present I could have ever had.
It was scary. She had lost weight and was tiny, she was only allowed small feeds and we had to be careful that she didn’t aspirate with fluid going down the wrong way.
For many nights I stayed awake until I literally couldn’t keep my eyes open, constantly waking and checking on her.
Lyla is doing really well now. She will have regular checks for the rest of her life to ensure that there is no further narrowing of the aorta and there is a chance she may require further surgery as she grows, but it’s unknown. Her big sister, Lula, has recently had her heart checked too – just in case – thankfully she was given the all clear.
Lyla had a dramatic first few months and we are very happy that she has come out the other side, but I do wish her heart condition had been picked up earlier.
It never crossed my mind my newborn could have a heart condition, naively thinking if anything was wrong it would have been picked up in a pregnancy scan or in existing mandatory newborn tests.
Detecting a baby’s heart problem early can give them a greater chance of survival and reduce the risk of other health problems. But it also means that families are given the chance to prepare for, what can be, a truly traumatic time.
For more information please contact Emma McKinney, Communications Manager (Health Sciences), University of Birmingham, tel: +44 (0) 121 414 6681, or contact the press office on +44 (0) 7789 921 165.
Notes to editors:
- The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
- The PulseOx study, which involved 20,000 babies across the West Midlands, found the test was successful in identifying newborn babies with serious heart conditions developed in the womb, and other important conditions such as infections and breathing problems, that can go undetected during antenatal ultrasound scans and initial examinations.
- Birmingham Women’s and Children’s NHS Foundation Trust (BWC) brings together the very best in paediatric and women’s care in the region and is proud to have many UK and world-leading surgeons, doctors, nurses, midwives and other allied healthcare professionals on its team.
- Birmingham Women’s Hospital is a centre of excellence, providing a range of specialist health care services to over 50,000 women and their families every year from Birmingham, the West Midlands and beyond. As well as delivering over 8,200 babies a year, it offers a full range of gynaecological, maternity and neonatal care, as well as a comprehensive genetics service, which serves men and women. Its Fertility Centre is one of the best in the country, while the fetal medicine centre receives regional and national referrals. The hospital is also an international centre for education, research and development with a research budget of more than £3 million per year. It also hosts the national miscarriage research centre – the first of its kind in the UK - in partnership with Tommy’s baby charity.
- The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:
- Funds, supports and delivers high quality research that benefits the NHS, public health and social care
- Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
- Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
- Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
- Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
- The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.
(i) Oddie et al (2019). ‘UK consultation on pulse oximetry screening for critical congenital heart defects in newborns’. The Lancet. DOI: 10.1016/ S0140-6736(19)31515-6
This article was written by Professor Ewer; Dr Sam Oddie, of Bradford Royal Infirmary and the University of York; Professor Ben Stenson, of the Royal Infirmary of Edinburgh and the University of Edingburgh, and Professor Jonathan Wyllie, of The James Cook University Hospital and the University of Durham.
(ii) Plana et al (2018). ‘Pulse oximetry screening for critical congenital heart defects’. Cochrane Database of Systematic Reviews 2018, Issue 3. Art. No.: CD011912. DOI: 10.1002/14651858.CD011912.pub2.