Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration (NCT07442669) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration
United States100 participantsStarted 2026-07-01
Plain-language summary
This prospective randomized controlled study aims to determine if using a lung ultrasound score can lead to a faster diagnosis of severe respiratory distress syndrome and quicker administration of surfactant in moderately and late-preterm infants. The research will involve 100 infants, with 67 in the prospective group and 33 serving as controls.
The primary goal is to shorten the time to treatment for these vulnerable newborns. The study will also assess whether this ultrasound-guided approach improves short-term respiratory outcomes. These secondary objectives include measuring any decrease in the need for and duration of mechanical ventilation, the length of non-invasive respiratory support, and the overall need for oxygen.
The study population includes infants born between 27 and 34 6/7 weeks of gestation who are admitted to the NICU. Each participant will be monitored from birth until they are discharged or transferred. This research aligns with a growing body of evidence suggesting that lung ultrasound can be a valuable tool in neonatal care, potentially leading to earlier and more precise treatment for respiratory distress syndrome.
Who can participate
Age range
27 Weeks – 34 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inborn at 27 0/7 to 34 6/7 weeks of gestational age
* Spontaneously breathing at birth but requiring non-invasive respiratory support
* RDS diagnosed on chest x-ray (diffuse, bilateral, fine granular opacities in lungs, air bronchograms) or were at risk of developing RDS
Exclusion Criteria:
* Outborn
* Endotracheal intubation in the delivery room or within 2 hours of life
* Surfactant in the delivery room as part of advanced resuscitation
* Presence of major congenital malformations or chromosomal anomalies
* Hydrops fetalis
* Inherited disorders of metabolism
* Air leak syndrome (pneumothorax, pneumomediastinum) prior to surfactant administration, congenital diaphragmatic hernia, congenital pneumonia, meconium aspiration syndrome
* Infants in extremis not expected to survive
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a lung ultrasound score to decide whether a premature baby needs surfactant through a method called LISA — can you explain what the LISA method involves and how it differs from more traditional ways of giving surfactant to newborns?
2Since this trial is listed as 'not yet recruiting,' how far away is it from opening, and are there currently available standard-of-care options for managing my baby's respiratory distress syndrome that we should be pursuing in the meantime?
3The trial is phase 'NA,' which suggests it may be focused on evaluating a diagnostic or decision-making process rather than a new drug — does that mean my baby would still receive standard surfactant treatment, just with a different tool guiding the timing?
4One of the main things being measured is the time it takes to give surfactant after the lung ultrasound — why does the speed of surfactant delivery matter for a premature baby with respiratory distress syndrome, and could delays in that process pose any additional risk?
5Given that this study is specifically for newborns with respiratory distress syndrome, what criteria would determine whether my baby might eventually be considered for this trial, and what would participation actually look like day-to-day in a neonatal unit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Lung Ultrasound
Timeframe: From date of birth to until the date/time of the lung ultrasound or date of death from any cause, assessed up to 1 week of life
2
Time to surfactant administration via LISA method
Timeframe: From date of birth to until the date/time of first documented progression (surfactant administration) or date of death from any cause, assessed up to 1 week of life