Lung ultrasound score to guide surfactant timing in preterm newborns
Official title: Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration: A Pilot Study
Run by Hackensack Meridian Health · NCT07442669 · Data updated 2026-11-12
This study tests whether using a lung ultrasound score can speed up diagnosing severe RDS and getting surfactant to moderately and late-preterm babies in the NICU.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 27 Weeks to 34 Weeks |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hackensack Meridian Health Academic / other |
| Locations | 1 site (Hackensack, New Jersey) |
| Status | Recruiting |
| Started | August 18, 2026 |
| Main results expected | August 17, 2028 |
| Study ends | August 17, 2028 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07442669 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Inborn infants born at 27 0/7 to 34 6/7 weeks who spontaneously breathe at birth but require non-invasive respiratory support and have or are at risk of RDS.
✕Probably not a fit
Infants not meeting criteria for non-invasive support or those requiring immediate intubation or with major congenital anomalies may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective randomized trial enrolling 100 inborn preterm infants between 27 0/7 and 34 6/7 weeks gestation who require non-invasive support. Infants are assigned to an ultrasound-guided strategy versus standard care to decide when surfactant should be given. The primary outcome is time to treatment, with secondary outcomes including short-term respiratory results, duration of ventilation, non-invasive support, and oxygen exposure. The trial uses lung ultrasound as the key intervention to inform management decisions. Conducted at Hackensack University Medical Center, the study aims to balance timely treatment with avoidance of invasive ventilation where possible.
Why it matters
Potential benefit: If successful, the approach could shorten time to surfactant and improve short-term breathing outcomes for preterm infants.
How similar studies have gone: Previous evidence supports using non-invasive strategies to guide surfactant, but the specific ultrasound-guided timing approach is a recent and less-established strategy in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hackensack Univeristy Medical Center
Hackensack, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Sandy Cheung, DO — Hackensack Meridian Health
- Study coordinator: Jeanette Buljevich Haugh
- Email: jeanette.haugh@hmhn.org
- Phone: 5519963457
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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.