A Study of the Safety and Efficacy of AeroFact in Preterm Infants with RDS

• Research type

  Research Study

• Full title

  A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of AeroFact (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) in Preterm Infants with Respiratory Distress Syndrome

• IRAS ID

  1008664

• Contact name

  Shannon Strom

• Contact email

  sstrom@aerogenpharma.com

• Sponsor organisation

  Aerogen Pharma, Ltd.

• Clinicaltrials.gov Identifier

  NCT06776783

• Research summary

  This clinical trial is a phase 3 study testing the safety and effectiveness of AeroFact™, a new inhalable surfactant treatment, in preterm infants with respiratory distress syndrome (RDS). RDS is a common condition in premature infants where their lungs are not fully developed, making it hard for them to breathe on their own.
  AeroFact™ combines a natural substance called a surfactant (SF-RI 1) with a special delivery system. Surfactants help keep the tiny air sacs in the lungs (alveoli) open, preventing them from collapsing and making breathing easier. Unlike traditional surfactant treatments that require inserting a tube into the windpipe (a more invasive procedure), AeroFact™ is inhaled through less invasive methods like nasal Continuous Positive Airway Pressure (nCPAP) or Non-Invasive Ventilation (NIV).
  The main goal of this study is to see if AeroFact™ can reduce the number of premature babies who experience failure of their current breathing support (nCPAP/NIV) within the first seven days of life. Importantly, the researchers want to ensure that AeroFact™ does this without increasing any other serious health problems related to being born prematurely.
  In the study, premature infants born between 26 and 33 weeks of gestation with RDS, requiring nCPAP or non-invasive ventilation, are randomly assigned to one of two groups:
  1. AeroFact™ Group: Babies in this group will switch to using the AeroFact™ delivery system and start receiving the AeroFact™ treatment.
  2. Control Group: Babies in this group will switch to using the AeroFact™ delivery system and be maintained at the same level of nCPAP/NIV support .

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  25/NS/0137

• Date of REC Opinion

  21 Jan 2026

• REC opinion

  Further Information Favourable Opinion