Actively Recruiting

Phase Not Applicable
Age: 0Hours - 2Hours
All Genders
NCT06446453

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

Led by Connecticut Children's Medical Center · Updated on 2025-06-05

52

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0Hours - 2Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The infant's parent or legal guardian can understand and willingly sign a written informed consent document for this study
  • Birth gestational age between 27 weeks 0 days and 36 weeks 6 days
  • Diagnosis of respiratory failure secondary to respiratory distress syndrome requiring respiratory support with non-invasive positive pressure ventilation
Not Eligible

You will not qualify if you...

  • Unable to obtain lung ultrasound between 1 to 2 hours of life
  • Infants already intubated or who received surfactant before the point-of-care lung ultrasound
  • Infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations
  • Infants born with chromosomal abnormalities
  • Infants with APGAR scores 5 or less at 10 minutes of life
  • Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Connecticut Children's

Hartford, Connecticut, United States, 06106

Actively Recruiting

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Research Team

J

Jacob Kelner

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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