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

NCT06446453 | Recruiting DMC

• 1 other identifier: 24-005-CCMC
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation Index

  (CPAP Level x FiO2)/(SpO2)

  At 24 hours of life.

Secondary Outcomes (1)

• Oxygen Saturation Index

  At 48 and 72 hours of life.

Study Arms (2)

Control

NO INTERVENTION

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.

Treatment

EXPERIMENTAL

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)

Interventions

Echography-guided Surfactant THERapy (ESTHER) DIAGNOSTIC_TEST

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

Treatment

Eligibility Criteria

• Age: 0 Hours - 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's

Hartford, Connecticut, 06106, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jacob Kelner

  Connecticut Children's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Kelner

CONTACT

860-545-9720; jkelner@connecticutchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal-Perinatal Fellow

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 6, 2024
• Study Start: June 25, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)