Vermont Oxford Network (VON), in partnership with the African Neonatal Network and P-95, through an investment from the Gates Foundation, has launched a clinical trial that gathers evidence to inform the development of future global guidelines related to treatment of infants with respiratory distress syndrome (RDS) in resource-limited settings. RDS is the leading cause of preterm infant death, and the trial is testing a treatment option that can overcome many of the barriers of effective treatment currently faced by hospitals in Low- and Middle Income Countries.

The Surfactant Administered via Supraglottic airway versus InSurE (SASI) Trial, will compare two methods of administering surfactant. The current standard method involves visualizing the vocal cords and intubation of preterm infants, which requires extensive training and expensive materials to administer. New technology and devices appropriately sized for preterm infants have made it possible for care teams to use a less invasive supraglottic airway method of delivery, which allows the infant to inhale surfactant without vocal cord visualization and intubation. This less-invasive method also requires less training and equipment, so if it is proven effective, teams can use the existing network of hospitals in the African Neonatal Network to spread education and training.

The SASI trial is the first large clinical trial for neonatal care for the three participating hospitals: St. Paul’s Hospital Millenium Medical College (Ethiopia), Kenyatta National Hospital (Kenya), and Lagos State University Teaching Hospital (Nigeria). VON is serving as the trial’s data coordinating center, partnering with St. Paul’s Hospital Millennium Medical College, the sponsoring academic institution. Ethiopia’s Dr. Mahlet Abayneh and VON’s Dr. Danielle Ehret and Dr. Erika Edwards are serving as lead principal investigators, supported by P-95, a clinical trial support organization based in South Africa.

“We are looking forward to working with dedicated partners and clinical leaders in Ethiopia, Kenya, and Nigeria to create evidence, hopefully leading to establishing evidence-based, practical and effective ways to administer life-saving RDS treatment to countless infants cared for in hospitals in the African Neonatal Network and beyond,” said Dr. Danielle Ehret, VON Chief Medical Officer and Director of Global Health. “The ANN provides an incredibly effective structure to disseminate training and can accelerate the uptake of evidence-based practices in neonatal care.”