Less invasive surfactant administration during high-flow oxygen in late preterm and early term infants
Official title: Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress?
Run by King's College Hospital NHS Trust · NCT06421506 · Data updated 2026-11-12
This study tests whether giving surfactant with a less invasive method during high-flow oxygen reduces the need for invasive ventilation in babies born 34 to 38 weeks who have breathing problems after birth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 34 Weeks to 38 Weeks |
| Sex | All |
| Enrollment | 245 (estimated) |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | May 8, 2024 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06421506 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born at 34+0 to 38+6 weeks gestation who require non-invasive respiratory support and meet specific respiratory distress criteria within the first 24 hours of life.
✕Probably not a fit
Babies requiring immediate intubation at birth or those with severe congenital anomalies may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study investigates whether administering surfactant via a less invasive technique (LISA) to infants receiving high-flow nasal cannula oxygen can lower the proportion of babies who require invasive mechanical ventilation within 72 hours of birth. Eligible participants are neonates born at 34+0 to 38+6 weeks of gestation who show respiratory distress and are on non-invasive respiratory support. The trial compares LISA during HFNC to standard non-invasive care without LISA, aiming to determine if the approach improves breathing support while reducing complications associated with ventilation. The investigation will monitor safety and clinical outcomes related to non-invasive versus invasive respiratory strategies in this specific gestational window.
Why it matters
Potential benefit: If successful, the approach could reduce the need for invasive ventilation and its risks in late preterm/early term infants with respiratory distress.
How similar studies have gone: Past research suggests that less invasive surfactant strategies can reduce ventilation needs in preterm infants, but results vary by gestational age and respiratory support method.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
King's College Hospital
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Theodore Dassios, PHD — King's College London
- Study coordinator: Eleanor Jeffreys, MBBS
- Email: eleanor.jeffreys@nhs.net
- Phone: +447519 974813
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.