SurfON
Research type
Research Study
Full title
Multicentre, open-label, randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress.
IRAS ID
269023
Contact name
Professor Elaine M Boyle
Contact email
Eudract number
2019-003764-45
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
This study is about babies born two to six weeks before their due date. Babies born even a few weeks early are not fully developed. These babies may have breathing problems after birth, 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. We can give a dose of surfactant into the lungs- down a small tube in the windpipe and many of the most premature babies are given it routinely. In babies born closer to term it is harder to predict who will need surfactant and who will get better without it.
There have been no research studies in babies born two to six weeks early with breathing problems. We want to know if it is better to give surfactant early, when a baby first starts to need help with breathing, or wait to see if they improve without it.
Summary of Results
The SurfON trial was a research study involving babies born late preterm and early term (that is, between 34 and 38 weeks of pregnancy), who developed breathing problems shortly after birth.
Babies born before their due date can sometimes have breathing difficulties because their lungs may not produce enough surfactant. Surfactant is a natural substance that helps keep the lungs open and makes breathing easier. Surfactant treatment is routinely used in very premature babies, but doctors have been uncertain about the best time to give this treatment to babies born only a few weeks early with breathing difficulties.
The SurfON trial compared two approaches to care. One group of babies received surfactant treatment early after breathing problems developed, while the other group were carefully monitored and only received surfactant later if it became necessary. A total of 1515 babies took part in the study across 45 hospitals in the United Kingdom.
The trial found that babies who received surfactant early stayed in hospital for a similar length of time to babies who were monitored and treated only if needed. The number of babies who developed more severe breathing problems prior to being discharged home was also similar in both groups.
Overall, the study did not show a benefit from giving surfactant treatment early compared with careful monitoring and selective treatment when required. These findings will help guide doctors caring for late preterm and early term babies with breathing difficulties.
The study results are currently being prepared for publication in a medical journal and have also been shared with healthcare professionals involved in newborn care.REC name
East Midlands - Derby Research Ethics Committee
REC reference
20/EM/0003
Date of REC Opinion
14 Feb 2020
REC opinion
Further Information Favourable Opinion