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Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure

NCT06446453 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-06-05

No results posted yet for this study

Summary

Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. POCUS can be used to diagnose the severity of neonatal respiratory distress syndrome (RDS) through a lung ultrasound score. Lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. Therefore, using lung ultrasound scores to guide surfactant therapy for RDS will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. This study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with RDS with our current surfactant administration guidelines.

Conditions

  • Respiratory Distress Syndrome, Newborn
  • Pulmonary Surfactants
  • Intensive Care Units, Neonatal

Interventions

DIAGNOSTIC_TEST

Echography-guided Surfactant THERapy (ESTHER)

Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score.

Sponsors & Collaborators

  • Connecticut Children's Medical Center

    lead OTHER

Principal Investigators

  • Jacob Kelner · Connecticut Children's

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
2 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446453 on ClinicalTrials.gov