Women and Children's Current Research

The Generation Study is a national research study that will sequence the genomes of 100,000 newborn babies to test for more than 200 rare and treatable genetic conditions. 

Identifying these conditions shortly after a baby is born, rather than when symptoms might appear later in childhood, means families can receive support, monitoring, and treatment much earlier. Early, effective intervention can help to prevent longer term health problems associated with certain conditions, keeping children out of hospital, and helping them live healthier lives. 

The Generation Study, led by Genomics England in partnership with NHS England, will see parents offered whole genome sequencing using blood samples taken from the umbilical cord shortly after birth.

In Bristol, Southmead Hospital (North Bristol NHS Trust) and St Michael’s Hospital (University Hospitals Bristol and Weston NHS Foundation Trust) are among more than 20 hospitals nationally taking part.

Women planning to give birth at home may also take part in the study. Expectant parents will be informed about the Generation study during pregnancy, and if interested, a research midwife will have a detailed conversation with them to decide if they want to take part. Taking part is voluntary and free. Soon after birth, an NHS doctor, nurse, or midwife will check with parents that they are still happy for their baby to be tested, and a blood sample will be taken and sent to a laboratory for whole genome sequencing.    

Results are then reviewed by NHS genomic scientists. The aim is to share results with parents within 28 days if a condition is suspected, or within a few months if no conditions are suspected. 

If a newborn baby is identified as having a treatable childhood condition through the genome sequencing, families and carers will be provided with further NHS testing to confirm a diagnosis and will receive ongoing support and treatment from the NHS. 

The study will also gather genomic data for wider research purposes, allowing a better understanding of rare genetic conditions. It will also potentially pave the way for new diagnostic tools and treatments and improvements in existing therapies.

In addition, the Generation Study will explore the risks and benefits of storing an individual’s genome over their lifetime. This could allow it to be reanalysed later in life if needed, enabling access to new developments in genomics.

For further information on the Generation Study, visit: www.generationstudy.co.uk

Principal Investigator – Dr Christy Burden 

Planned end date – Currently 31/03/2025.

Local Ref – 5527

 Digital Imaging versus Opthalmology for congenital cataract screening

About 1 in 3,000 babies are affected by cloudiness of the lens of the eye (cataract) and, in the majority of cases, both eyes are affected. Since a baby’s first months are a critical time for vision and brain development, early surgery is needed to prevent permanent visual impairment. For this reason, cataract is the most common cause of preventable child blindness worldwide. All babies born in the UK are examined (screened) for cataract twice: first, within 3 days of birth in the maternity unit, and then again at the 6-8 week check by their GP. Despite this, late diagnosis of cataract continues to be a problem, causing avoidable visual impairment in some affected children. In the standard examination test, midwives or doctors shine a bright white light torch (an ophthalmoscope) into the eye to assess the reddish reflected light (red-reflex), similar to “red eye” seen in flash photos. Cataract blocks the light reflection causing an absent or dim red-reflex. The test can be difficult to perform because the bright light causes the pupils to constrict and the babies to shut their eyes. The assessment is particularly difficult in babies with dark eyes since eye pigmentation affects the colour and brightness of the red-reflex. Recently, a handheld, non-contact camera, called Neocam, has been developed which takes a picture of the eyes using both infrared and green light. Previous small-scale studies have shown that this technique, called photoscreening, can make childhood cataract detection easier.  In this study, we want to find out if photoscreening is more accurate than the standard test for detecting cataracts in newborn babies.

Visit Divo website to complete the self-enrolment form.

Project Details

Principal Investigator: Dr Daniela Vieten-Kay

Planned end date: 30/6/2024

Local Ref: 5426 

A team of researchers and clinician are conducting a study of the use of a medication called Pravastatin by pregnant women who have been identified as being at higher risk of their babies being born too early (preterm birth).

Preterm birth is birth that happens before 37 weeks of pregnancy. It affects around seven out of every 100 babies born in the UK. We do not fully understand why some babies are born too early and at present there are few effective treatments to prevent this from happening. Research shows it is likely that early labour may occur in some pregnancies because of inflammation in the mother’s body. Taking a medication that reduces inflammation, such as Pravastatin, could therefore reduce the number of babies being born too early. Pravastatin is a statin, and statins are a group of medicines which are commonly taken to help lower the risk of heart disease and stroke. Statins work by protecting blood vessels and lowering inflammation in the body.

During the past couple of decades, Pravastatin has been used during pregnancy in studies which have investigated whether Pravastatin prevents or treats other problems/complications of pregnancy. In total 1,303 pregnant women took part in these studies, which showed that there were no safety concerns or problems regarding the baby’s development.

In fact, these studies suggested benefits to the baby, as they found evidence that Pravastatin reduced the number of babies born early. This is what PIONEER will now test. Based on this information, we are interested to find out whether treatment with Pravastatin reduces the chance that a woman will give birth early by: 

• extending the length of pregnancy
• reducing the risks associated with babies being born too soon. 

We would also like to find out how Pravastatin might work to reduce early birth by looking at blood samples, vaginal swabs, and stool samples taken from pregnant women who take part in the study.

Everyone who takes part in PIONEER will be randomised into one of two groups: one group will take Pravastatin and the other group will take a placebo (a dummy tablet which looks like Pravastatin but does not contain Pravastatin, only an inactive substance). An equal number of pregnant women will be placed in each group. The aim is to have two groups that are as similar as possible at the start of the study, so that the only thing that differs between the groups is whether they receive the Pravastatin or the placebo. This then allows a fair comparison between the two groups to see if there are differences between the groups in the number of babies born early.

For more information, please visit the study website www.bristol.ac.uk/pioneer

Principal Investigator – Dr Sherif Abdel-Fattah

Planned end date – 31/03/2027.

Local Ref - 5406

Children of the 90s is a group of around 14,500 children born in the Avon area in 1991 and 1992. Scientists have been studying them ever since and are constantly making discoveries that make a difference to lives around the world.

Some now have children of their own, and we want to follow these pregnancies, births and babies. We call this Children of the Children of the 90s, or COCO90s for short. This is the only project we know of that provides scientists with information on three generations, allowing them to study important social and health issues.

If you or your partner are in Children of the 90s and are about to become or are already a parent, we'd love you, your partner and all your children to take part in COCO90s. It doesn’t matter how much or how little you have been involved in Children of the 90s in the past -- this is a new opportunity to be involved in ground-breaking research.

For more information about this study, visit the CoCo90s website.

Project Details
Principal Investigator: Ms Mary Alvarez
Planned end date: Ongoing
Local Ref: 2801

Aim: The DOLFIN trial is a research study looking at whether giving a specially developed nutritional supplement via breast or formula milk for the first year of life helps with brain development. If your baby was born less than 28 weeks old or is receiving cooling therapy, you may be approached about the study.

Recruitment: 30 babies born at less than 28 weeks or receiving cooling therapy.

A small UK study has been carried out and the results were promising, but we need to find out more.  About 500 babies nationally will take part in the study so that we can find out whether the supplement improves neurological child development. Half will receive the nutrient supplement and half will a get a dummy (placebo). You will not know which treatment your baby will receive.  Joining the study involves you giving the supplement daily to your baby until the date they would have turned one.

For more information, please visit the DOLFIN trial website.

Project Details
Principal Investigator: Dr Amiel Billietop
Planned end date: 31/05/2024
Local Ref: 5131

Aim: This research project compares two ways we may adjust a commonly used treatment, called positive end-expiratory pressure (or PEEP), to help premature babies’ lungs in the first few minutes after birth.  

Recruitment:  80 babies born before 29 weeks of pregnancy.

The POLAR Trial is a large clinical trial, being conducted in 25 hospitals around the world, including Australia, Europe, the United Kingdom and the USA.​

​This trial will establish how to best support the fragile lungs of very premature babies born between 23 and 28 weeks of pregnancy immediately after birth.​

We are comparing two approaches to PEEP levels given to preterm babies’ lungs at birth. We will put your baby into one of two groups, static or dynamic PEEP.  

All the babies in the same group receive the same treatment.  The results are later compared to see if one is better. 

For more information, please visit the POLAR study website.                                                                                          

Project Details
Principal Investigator: Dr Charles Roeher
Planned end date: 30/06/2026
Local Ref: 5152

Aim: To investigate whether in late preterm and early term infants with respiratory distress the early use of surfactant versus expectant management results in a shorter duration of hospital stay and fewer infants who fail to respond to treatment.

Recruiting: Infants born between 34+0- and 28+6-weeks’ gestation admitted to a Neonatal Unit (NNU) with respiratory distress and for whom a clinical decision has been made to provide non-invasive respiratory support.

For more information, please visit the SurfOn website.

Project Details
Principal Investigator: Dr Amiel Billietop
Planned end date: 28/02/2025
Local Ref: 4949

Aim: The WHEAT International trial will compare two different approaches, feeding babies or not feeding babies during blood transfusions, to work out which one is better. 

Recruitment: We are including all babies that are born before 30 weeks of pregnancy. The WHEAT study is an opt-out study.  This means that all babies will take part unless you let a member of the neonatal team that you do not wish your baby to participate. 

Both approaches are standard practice in the UK but we don’t how best to feed babies during blood transfusions – some hospitals and doctors stop feeds while other don’t. 

Some babies who are born early can develop a bowel disease called necrotising enterocolitis (NEC) which can be serious and can have long-term effects on how babies grow and develop. We want to know if feeding babies or not feeding babies while they have a blood transfusion changes the number of babies that get NEC.

WHEAT is taking places in neonatal units across the UK and Canada and will involve about 4,500 babies.

Project Details
Principal Investigator: Dr Daniela Vieten-Kay
Planned end date: 31/12/2025
Local Ref: 5236

Aim: The neoGASTRIC study is looking at whether routinely measuring gastric residual volumes (checking what is in the stomach before feeding) helps babies safely get to full feeds more quickly. We are comparing two ways of caring for babies having tube feeds, both ways are standard care commonly used in neonatal units across the UK.

Recruitment: We are including all babies born 6 or more weeks early (before 34 weeks of pregnancy) who require tube feeding unless there is another medical reason why they should not take part. All babies will be in the study unless you let a member of the neonatal team know that you do not wish your baby to take part.

Some doctors and nurses routinely measure gastric residual volumes because they think it might help tell if the baby is coping with their feeds, and may help identify signs of a serious but rare gut disease called necrotising enterocolitis (NEC). Other doctors and nurses think that routinely measuring gastric residual volumes may not be a good idea because it can be inaccurate and we do not know if it does help to identify necrotising enterocolitis (NEC). It also increases the amount of procedures each baby has, and may be uncomfortable for them. Routinely measuring gastric residual volumes may also lead to feeds being reduced or even stopped, this will delay the time it takes for the baby to reach full feeds and might affect how well they grow. It will also mean a baby will need intravenous nutrition for longer which can lead to potential problems like infections.

In the UK about half of doctors and nurses routinely measure gastric residual volumes and about half don’t – so both approaches are standard treatment. 

The study is being run in more than 30 hospitals in the UK and Australia for about 3 to 4 years. We hope to include over 7000 babies in the study (UK and Australia combined).

Project Details
Principal Investigator: Paula Brock
Planned end date: 31/06/2026
Local Ref: 5298