SURFactant Administration by SUPraglottic Airway (SURFSUP Trial)

• Research type

  Research Study

• Full title

  A multicentre, randomised controlled, non-inferiority trial, comparing surfactant administration by supraglottic airway compared to endotracheal catheter in preterm infants (the SURFSUP Trial)

• IRAS ID

  288405

• Contact name

  Joyce O'Shea

• Contact email

  joyce.o'shea@ggc.scot.nhs.uk

• Sponsor organisation

  Monash Newborn

• Clinicaltrials.gov Identifier

  U1111-1258-2109 , WHO Universal Trial Number; ACTRN12620001184965, ANZCTR Trial ID

• Duration of Study in the UK

  4 years, 0 months, days

• Research summary

  Respiratory distress syndrome (RDS) is a condition commonly found in premature babies that causes breathing difficulty soon after birth. Many babies respond to breathing support alone, but some need surfactant, a liquid drug given into the baby’s airway.
  Traditionally, the standard method to administer surfactant is through a tube inserted into the airway by the treating doctor. The doctor first needs to visualise the baby’s airway using a laryngoscope (a metal device that holds the airway open), placed into the baby’s mouth and positioned correctly. The tube can then be inserted under direct vision. This method is very effective, but is challenging to learn, and may take more than one attempt even for experienced doctors. It is also painful for babies and some may briefly drop their heart rate or oxygen levels.
  Previous research and our clinical experience suggests that an alternative method to give surfactant can be through a supraglottic airway. ‘Supraglottic airways’ are a different type of airway tube. They are inserted through the mouth and form a seal over the airway opening without needing to visualise the airway. They are easier to use for doctors and more comfortable for babies. We do however not yet know if this method is as effective as the standard method.
  This research study will compare the new method, supraglottic airway surfactant treatment, with the traditional standard method, through a tube inserted into the airway. We will measure how stable babies are during treatment, including their oxygen levels and heart rate. We will also record how many babies need a higher level of breathing support (ventilation by a breathing tube). If supraglottic airway surfactant treatment can be used safely and effectively, and is more comfortable and easy to use, it could become the preferred method of surfactant treatment for babies with RDS.

• REC name

  London - Camden & Kings Cross Research Ethics Committee

• REC reference

  22/LO/0388

• Date of REC Opinion

  3 Aug 2022

• REC opinion

  Further Information Favourable Opinion