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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Distress Syndrome, Newborn; Intensive Care Units, Neonatal; Pulmonary Surfactants
• Intervention / Treatment: Diagnostic test: Echography-guided Surfactant THERapy (ESTHER)

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob Kelner; Phone Number: 860-545-9720; Email: jkelner@connecticutchildrens.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Connecticut Children's
      • Contact: Little

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study
• Birth gestational age between 27w0d-36w6d
• Diagnosis of respiratory failure secondary to RDS requiring respiratory support with non-invasive positive pressure ventilation

Exclusion Criteria:

• Unable to obtain lung ultrasound between 1-2 hours of life
• Infants already intubated or 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 APGARs ≤ 5 at 10 minutes of life
• Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control group will receive surfactant therapy based on our unit's current surfactant guidelines, including but not limited to a FiO2 requirement ≥ 0.3 on non-invasive positive pressure ventilation.
Experimental: Treatment; The treatment group will receive surfactant therapy if the initial LUS at 1-2 hours of life is > 9 or if they meet our unit's current surfactant therapy guidelines (irrespective of the LUS).	Diagnostic test: Echography-guided Surfactant THERapy (ESTHER); Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation Index	(CPAP Level x FiO2)/(SpO2)	At 24 hours of life.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation Index	(CPAP Level x FiO2)/(SpO2)	At 48 and 72 hours of life.

Collaborators and Investigators

• Sponsor: Connecticut Children's Medical Center
• Investigators: Principal Investigator: Jacob Kelner, Connecticut Children's

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 1, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: 24-005-CCMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No