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Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 50 days later Jun 28, 2028 → Aug 17, 2028
See other at-risk trials from Hackensack Meridian Health

Record History

  1. Notable Recruitment openedv3 Show 4 more changesShow less
    • Primary completion pushed from Jun 28, 2028 to Aug 17, 2028
    • Study completion pushed from Jul 5, 2028 to Aug 17, 2028
    • Start date changed from estimate of Jul 1, 2026 to Aug 18, 2026
    • Site details revised
  2. Notable Start date: Mar 1, 2026 to Jul 1, 2026
    • Primary completion pushed from Feb 28, 2028 to Jun 28, 2028
    • Study completion pushed from Mar 5, 2028 to Jul 5, 2028
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07442669
Lead Sponsor Hackensack Meridian Health
Conditions
(from sponsor)
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Related terms Dyspnea, Respiratory Distress Syndrome, Newborn
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov