A UK-wide study funded by the National Institute for Health Research (NIHR) that is trying to find out how best to treat babies born two to six weeks early with breathing problems has opened at Leicester’s Hospitals, the lead NHS site for the trial.
The study, called SurfON (which stands for Surfactant Or Not) is for babies born two to six weeks before their due date with respiratory distress.
In the study, the babies are allocated by a computer into one of two groups. One group is given a treatment called surfactant soon after birth and babies in the other group are closely watched by healthcare professionals but no early surfactant is given.
Babies born even a few weeks early may not be fully developed and may have breathing problems, which can be severe. Some need to go onto a breathing machine (ventilator) soon after birth; others do not, but still need some help with breathing. They often go onto 'non-invasive' breathing support, which means that machines give oxygen through soft, short tubes in the nose or small masks over the nose.
The lungs of healthy full term babies produce surfactant, a substance that makes it easier for them to breathe. Babies born early often do not make enough surfactant, or their natural surfactant does not work properly. In the study, babies in the treatment group will receive a dose of surfactant into the lungs, down a small tube in the windpipe.
Professor Elaine Boyle, Leicester City FC Chair of Child Health at the University of Leicester and a consultant neonatologist at Leicester’s Hospitals, said: “There have been no research studies into when surfactant would be best given to babies born closer to term with breathing problems. This means healthcare professionals have no guidance on how best to treat these babies. Whilst some doctors prefer to use surfactant early, others do not and so clinical practice varies widely across hospitals in the UK.
“With the SurfON study, we aim to find out if it is better to give surfactant early - when a baby first starts to have problems - or wait and see if they will improve without it.
“We are delighted that Leicester’s Hospitals is the lead NHS site for the SurfON study, working with the University of Leicester as the study sponsor, and that we have already recruited our first baby into the study.”
Lexi-Grace Sketchley was born on 3 September at Leicester Royal Infirmary weighing a healthy 3kg. Despite being born at 37 weeks, she experienced problems with her breathing soon after delivery. She was given some breathing support and rushed to the neonatal unit for further help.
Lexi-Grace’s Dad, Shane Sketchley from Humberstone in Leicester, said: “I was in recovery with Mel, who had just had a c-section, when a member of the team came in and told us about the study and asked if we would take part. As a parent the last thing you want is to see your child suffering so we knew that if it could help Lexi, then yes, we’d go for it.”
By agreeing to take part, the researchers say that Lexi-Grace is thought to be the first baby in the world to be enrolled into a study focused specifically on late preterm and early term babies.
Within half an hour of entering the trial her oxygen levels were high enough to just rely on air. By the following morning she could breathe fully by herself and just seven days after her dramatic entrance into the world she was ready to go home.
Mel Beazeley, Lexi-Grace’s mum, added: “Lexi’s doing really well, she’s gaining weight, she’s really happy. It’s amazing. I can’t thank anyone at the hospital enough for what they’ve done, it’s brilliant.
The study is run by the National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU CTU) at the University of Oxford. The study is funded by the National Institute of Health Research (NIHR) [Health Technology Assessment (HTA) programme (Project reference 17/89/07) and sponsored by the University of Leicester.
For more information: Rachael Dowling, head of research communications, on firstname.lastname@example.org or +44 (0)7950 891193