Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method for helping premature babies breathe better when they are born with respiratory problems, specifically those born 2 to 6 weeks early. The researchers want to see if a technique called Less Invasive Surfactant Administration (LISA) can reduce the need for more intensive breathing support, known as invasive ventilation. LISA involves giving a substance called surfactant, which helps open up the lungs, through a small tube placed in the baby’s windpipe while they are awake. The babies will also receive oxygen through a device called a high-flow nasal cannula, which gently delivers warm, moist air through tubes in their nose.

To participate in this study, babies must be born between 34 and 38 weeks of pregnancy and need some help breathing right after birth but are stable enough to breathe on their own. The study will look at how many babies need invasive ventilation within 72 hours after birth, how long they stay in the neonatal unit, and how much this care costs. Researchers will also check the babies' lung function before and after receiving the surfactant treatment. This trial is not yet recruiting participants, but it aims to improve care for newborns with breathing difficulties.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support.
• • Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support.
• Exclusion Criteria:
• • Infants requiring intubation at birth
• • Infants with severe congenital anomalies.