Clinical trial Recruiting at 1 site Interventional Ages 34 Weeks to 38 Weeks

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 typeInterventional
Ages34 Weeks to 38 Weeks
SexAll
Enrollment245 (estimated)
SponsorKing's College Hospital NHS Trust
Academic / other
Locations1 site (London)
StatusRecruiting
StartedMay 8, 2024
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedAugust 6, 2026
Trial IDNCT06421506 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.