Women and Children's Current Research

 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 

Question: In women with pregnancy hypertension, what is the short-term blood pressure (BP) response to antihypertensive agents and how is this related to clinical effectiveness?

Recruitment: This study is open to some women who are already enrolled in the Giant PANDA study, from 13 weeks gestation up to birth.

The Baby PANDA study will look closely at the short-term changes in blood pressure in the hours after pregnant women take their blood pressure tablets.  We will also measure levels of certain markers in the blood and urine. We want to use this information to work out why some medication may suit some women more than others.

Project Details
Principal Investigator: Dr Christy Burden
Planned end date: 30/06/2024
Local Ref: 5283

Aim: To evaluate the effect of different antihypertensive drugs in women with pregnancy hypertension on maternal and fetal/neonatal outcomes

Recruiting: This study is offered to women between 11 and 36 weeks gestation who are taking medication to control their blood pressure

This study is looking at which blood pressure medication is best for pregnant women and people who are pregnant with high blood pressure and their babies.

We will compare two medications called labetalol and nifedipine. Both have been widely used to treat high blood pressure in pregnancy for many years. Both are considered safe in pregnancy.

Around half of participants taking part in this study will be asked to take labetalol and the other half nifedipine. The group you are in will be decided by chance. Your healthcare team would be happy with you having either.

For more information, please visit the study website.

Project Details
Principal Investigator: Dr Christy Burden
Planned end date: 30/06/2024
Local Ref: 5283

Aim: Whether women follow the NHS guidance on foods to avoid or limit during pregnancy, specifically on types of fish and game-meat/gamebirds, and whether is associated with biomarker concentrations of toxic metals

Recruitment: 300 women between 11-33 weeks gestation

Diet is an important factor for every pregnancy in the health and development of the baby. There’s plenty of advice and guidance on diet in pregnancy, including from the NHS, but we’d like to find out whether this advice really helps women to make positive changes to their diets at this important time, particularly guidance on foods to avoid or cut back on. We’d also like to know how your local environment affects your diet. As a result of the study, we’ll be able to suggest changes to the guidance that will make sure it’s clear, easy to access and simple to follow.

For more information, please visit the PEAR study website.

Project Details
Principal Investigator: Ms Sarah Coates
Local Ref: 5228

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

Around 8% of UK babies are born premature at birth and 12% of these are born between 30 and 33 weeks. Currently, most preterm babies are fed through a drip into their veins (intravenous) and given small amounts of milk by a small tube into their stomach, slowly increasing until they are fully milk fed. Doctors are wary of feeding premature babies with full milk straight after birth due to a potentially life-threatening gut condition called necrotising enterocolitis (NEC). Evidence suggests that in premature babies who aren't too poorly, larger milk feeds can be successfully given within 48 hours of birth without increasing the risk of NEC and death and could reduce the risk of severe infection.

We will compare the two different groups: the 'full milk' group will be given milk to provide all their fluid needs from the first day of life and increased over a few days unless they are struggling with this (e.g. if it makes them very sick). In the 'gradual milk' group, babies will be initially fed through their veins, increasing milk feeds slowly and reducing IV fluids until they are fully milk fed, which is current practice. Mothers will be identified at Antenatal clinic or within 3 hours of early arrival. The groups will be decided at random by a computer giving each baby an equal chance of being in either group.

We want to know if feeding babies with only milk from the first day of life can avoid babies having fluids through a drip (IV). It may be that giving milk only could reduce infections, reduce the number of days in hospital and therefore reduce the overall costs to parents and to the NHS.

For more information, please visit the study website.

Project Details
Principal Investigator: Dr Richard Wach
Planned end date: 31/09/2024
Local Ref: 4980

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

Aim: To compare laparoscopic removal versus diagnostic laparoscopy alone in terms of participants’ pain at 12 months post randomisation

Recruitment: 20 eligible women with endometriosis.

Around 50% of women with chronic pelvic pain will have a condition called endometriosis which can only be diagnosed by laparoscopy (a keyhole operation).  In women with endometriosis, cells similar to those lining the womb are found outside the womb on the lining of the pelvis (called the peritoneum).

We   want   to   determine   whether removing   superficial   peritoneal   endometriosis improves painful symptoms and quality of life, which surgical approach may be best (ablation or excision), or whether surgery is of no benefit, worsens symptoms or may even cause harm. For us to prove this, we will need 400 women to be entered into our national trial.

For more information, please visit the Esprit2 website.

Project Details
Principal Investigator: Dr Jessica Preshaw
Planned end date: 31/08/2024
Local Ref: 5217

Aim: To evaluate the potential benefit of Graduated Compression Stockings (GCS) in the prevention of Venous Thromboembolism (VTE) in patients undergoing short-stay surgical procedures, assessed as being at low-risk for VTE.

Recruitment: Women having surgery on Cotswold ward who meet the eligibility criteria

Status: Open to recruitment

People having short stay surgery (who either go home the same day or who stay overnight but go home shortly afterwards) are at a much lower risk of developing a blood clot than those who stay in hospital for longer. These low-risk people are often given elastic stockings (which squeeze the leg muscles) to reduce the chance of a blood clot. The risks of wearing the stockings are low but they can be uncomfortable. In the UK, there are over a million short stay surgeries performed each year and most of these people are given elastic stockings to wear. Stockings cost the NHS a lot of money and it remains unknown if they benefit these people.    

Project Details
Principal Investigator: Dr Iffy Offiah
Planned end date: 31/12/2024
Local Ref: 5200