New technique may spare tiniest babies from breathing tubes
NCT ID NCT04715373
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a method called LISA (Less Invasive Surfactant Administration) in extremely preterm infants (22-25 weeks). Instead of inserting a breathing tube, doctors gave lung medication through a thin catheter while the baby continued on CPAP. The goal was to see if this approach reduces the need for mechanical ventilation in the first 72 hours of life. Sixty infants were enrolled, and the study compared those who received LISA in the delivery room to those who got standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Poractant alfa (a natural lung surfactant) given via a thin catheter while the baby stays on CPAP
- What this could lead to
- If it works, this approach could help extremely preterm babies breathe with less invasive support, potentially lowering the risk of lung damage and other complications.
- What could go wrong
- This is a small, early feasibility trial with only 60 babies, so results may not apply to all preterm infants. The procedure itself carries risks, such as incorrect catheter placement or breathing instability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 20 minutes
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Infants born 22 -25 weeks GA * Resuscitated without requiring intubation and maintaining HR \>100, and spontaneous respiratory effort on CPAP 5-7 cm H2O) Exclusion Criteria: * Major congenital anomalies * Infants receiving only comfort care * Mothers with impaired decision making capacity
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Venkatakrishna Kakkilaya
Dallas, Texas, 75093, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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